Jobs at Click Therapeutics
249,921 open positions
Senior Manager, Computerized Systems Quality Assurance
Company: Kyverna Therapeutics
Location: Other US Location
Posted Apr 30, 2024
Kyverna Therapeutics is seeking a Senior Manager of Computer Software Assurance to lead a CSA program focusing on GAMP 5 and Health Authority compliance. The ideal candidate will have 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with expertise in computer systems validation, GAMP 5, Annex 11, or Part 11. The role involves creating and executing a CSA program, managing validation/qualification of systems, and supporting automation strategies for Kyverna's operations. The salary range is from $140,000 - $155,000 USD annually.
Principal Scientist, Pharmacology
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Apr 29, 2024
<div> <p><strong><em>Attention recruitment agencies<em><strong><em> All agency inquiries are vetted through 4DMTs internal Talent Acquisition team No unsolicited resumes will be accepted Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future<em><p> <p><br ><p><p>4DMT is a clinicalstage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines We seek to unlock the full potential of gene therapy using our platform Therapeutic Vector Evolution TVE which combines the power of directed evolution with our approximately one billion synthetic AAV capsidderived sequences to invent evolved vectors for use in our products We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles These profiles will allow us to treat a broad range of large market diseases unlike most current genetic medicines that generally focus on rare or small market diseases <p> <p>We have built a deep portfolio of AVVbased gene therapy product candidates with five product candidates in clinical trials 4D150 for the treatment of wet agerelated macular degeneration wet AMD and diabetic macular edema DME 4D710 for the treatment of cystic fibrosis lung disease 4D310 for the treatment of Fabry disease cardiomyopathy 4D125 for the treatment of Xlinked retinitis pigmentosa XLRP and 4D110 for the treatment of choroideremia In addition we have two product candidates in preclinical studies 4D175 for geographic atrophy GA and 4D725 for alpha1 antitrypsin deficiency<p> <p>Todate we have demonstrated clinical proofofconcept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors We have built a robust and efficient product engine with 6 open Investigational New Drug Applications INDs in the US 1 IND in Taiwan and 1 Clinical Trial Approval CTA in Australia We believe we are positioned to create develop manufacture and if approved effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases<p> <p>In addition to TVE our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material This internal capability and close collaboration between our RampD and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT<p> <p>Company Differentiators <p> <p> Fully integrated clinicalphase company with internal manufacturing<br > Demonstrated ability to move rapidly from idea to IND<br > Five candidate products in the clinic and two declared preclinical programs<br > Robust technology and IP foundation including our TVE and manufacturing platforms<br > Initial product safety and efficacy data substantiates the value of our platforms<br > Opportunities to expand to other indications and modalities within genetic medicine<p> <div> <p><span><span datacontrast=auto>GENERAL ROLE DESCRIPTION<span><span><span dataccpprops=> <span><p> <p><span datacontrast=auto>The Principal Scientist Pharmacology role will be in the Biomarkers amp Immunology group The group performs pharmacokinetic PK evaluations pharmacodynamic PD biomarker measurements immunogenicity risk assessments and exploratory clinical research during AAV product development Our responsibilities include both indepth data analysis and bioanalytical method development Methods are rigorously validated at CROs to characterize their performance and ensure that highquality data are generated Working closely with multiple crossfunctional stakeholders such as Clinical Sciences Pharmtox Clinical Operations Technology Innovation and Project Management our data deliverables and analyses have significant impact on key program decisions <span><span dataccpprops=> <span><p> <p><span datacontrast=auto>This role will report to the Senior Director of Biomarkers amp Immunology and be part of a talented motivated and creative team of scientists who are critical for the success of 4DMTs mission and development of our deep portfolio of targeted genetic medicines A flexible hybrid work schedule can be accommodated when analyzing data working on crossfunctional teams and remotely managing partner organizations<span><span dataccpprops=> <span><p> <p><span datacontrast=none>PRIMARY RESPONSIBILITIES<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=none>Representing Biomarkers amp Immunology function on crossfunctional teams<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=none>Leading subteams responsible for analysis of PK PD biomarkers immunogenicity and molecular endpoints in investigational AAV therapeutics programs<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=none>Utilizing appropriate scientific approaches to understand characteristics of AAV vectormediated gene expression and transgenic protein function<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=none>Collaborating with bioanalytical teams to forecast analytical requirements for projects and assess suitable method performance<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=none>Leveraging a strong understanding of bioanalytical assays to analyze and interpret data to drive key decisions in AAV product development eg FIH dose selection<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=none>Leading design execution and analysis of PKPD biodistribution metabolism germline transmission and shedding studies in AAV therapeutics programs<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=none>Assessing potential impact from immunogenicity of therapeutic candidates on PK PD biomarkers and clinical efficacy or safety endpoints<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=none>Applying quantitative skills to support modelbased drug development and address complex issues via modeling and simulation eg candidate selection dose optimization<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=none>Contributing to the design and implementation of nonclinical and clinical studies including INDenabling studies<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=none>Designing experiments analyzing data using nextgen analytical techniques and presenting data to line management study teams and regulatory agencies<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=none>Effectively mentoring junior level staff and acting as a resource for scientific expertise<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=auto>Support the preparation of content for regulatory interactions and submissions eg preIND Briefing Books IND filings Orphan Drug Designation EMA submissions <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=none>Maintaining current awareness of scientific literature and regulatory guidance<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=none>Writing and reviewing technical documents study protocols and reports manuscripts and presenting results at scientific meetings<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=none>Maintaining compliance with company Environmental Health and Safety policies procedures and practices<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=29 datalistdefnprops= dataariaposinset=16 dataarialevel=1><span datacontrast=none>Contributing to building a culture that embraces continuous learning improvement and innovation and encourages team members to expand their skill base and deepen their gene therapy expertise<span><span dataccpprops=> <span><li> <ul><p><span dataccpprops=> <span><span><span datacontrast=none>QUALIFICATIONS<span><span dataccpprops=> <span><span><p> <p><span datacontrast=none>Education amp Experience<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=none>PhD in pharmacology pharmaceutics pharmacokinetics and metabolism pharmacometrics biomedical engineering computational biology or related field<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=none>10+ years of industry experience with relevant pharmaceutical development experience<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=none>Independent scientist with strong background in ADME andor clinical pharmacology<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Strong scientific acumen as demonstrated by first or last author publications in peerreviewed scientific journals and ability to work in a matrixed environment <span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Previous experience in crossfunctional teams and work in a scientific or clinical setting supporting drug development<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Experience with AAV therapeutics development is preferred<span><span dataccpprops=> <span><li> <ul><p><span dataccpprops=> <span><span><span datacontrast=none>Skills<span><span dataccpprops=> <span><span><p> <ul><li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=none>Successfully demonstrated ability to conduct research with strong attention to detail and rigorously analyze and interpret PKPD biomarker and immunogenicity data<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=none>Sound knowledge of DMPK and PKPD analysis principles experience in PKPD modeling and simulation is highly desirable<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=none>Proficiency in common pharmacometrics software such as Phoenix WinNonlinNLME NONMEM Watson MONOLIX WinBUGS STAN Matalab R or S+<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=none>Working knowledge of FDA EMA and ICH guidances relevant for AAV therapeutics development immunogenicity assessments and bioanalytical methods<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=none>Ability to multitask and support more than one project simultaneously<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=none>Highly organized and motivated selfstarter with strong analytical and problemsolving skills<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=none>Strong work ethic flexibility and cooperative cando attitude<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=none>Ability to work in a teambased environment supportive of multiple viewpoints and approaches<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=none>Strong communication skills both written and oral with demonstrated ability to present ideas information and data effectively via oneonone discussions team meetings and external partnership interactions<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=16 dataarialevel=1><span datacontrast=none>Understanding and knowledge of key scientific software programs including Microsoft Office JMP or Prism Adobe Photoshop<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=none>Base salary compensation range<span><span dataccpprops=> $ 182000yr $217000yr<span><p> <p><span dataccpprops=>Please note that compensation varies on experience location and other factors<span><p> <div> <p>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws<p> <p> <p> <p>Equal Opportunity EmployerProtected VeteransIndividuals with Disabilities<p> <div>
Principal Scientist, Process Development
Company: Cerevel Therapeutics
Location: Boston, MA
Posted Apr 30, 2024
Cerevel Therapeutics is a company dedicated to developing innovative therapies for central nervous system disorders. They are seeking a talented synthetic organic chemist to join their Process Development team as a Principal Scientist.
Associate Director, DMPK
Company: Maze Therapeutics
Location: Peninsula
Posted Apr 29, 2024
Maze Therapeutics is seeking an Associate Director, DMPK to lead and manage the discovery efforts of the DMPK group. The ideal candidate will have a PhD in a relevant field with 6+ years of experience in DMPK and strong general knowledge of pharmacokinetics and drug metabolism concepts.
National Field Training Manager
Company: Corcept Therapeutics
Location: Peninsula
Posted Apr 29, 2024
Corcept is a leading company in the research and development of cortisol modulators, with over 1,000 proprietary molecules discovered. They received FDA approval for Korlym® (mifepristone) in 2012, the first treatment for hypercortisolism (Cushing syndrome). Currently, they have more than 30 ongoing studies across various disease areas, including endocrinology, oncology, metabolism, and neurology. The National Field Training Manager will provide initial and ongoing training for Clinical Specialists and the Salesforce, focusing on observing CS activities and deploying training curriculum. The role involves conducting field rides, assisting in product training frameworks, executing commercial training programs, and facilitating workshops. The pay range for this position is $165,000 - $180,000, with 50% travel required. Corcept is an Equal Opportunity Employer.
Head of Development & PV QA & QC
Company: Esperion Therapeutics
Location: Ann Arbor, MI
Posted Apr 30, 2024
Esperion is a remote-based company dedicated to developing and commercializing oral LDL-C lowering therapies for hypercholesterolemia patients. The company offers competitive compensation and benefits, and is committed to quality and patient safety. The Head of Development and Pharmacovigilance Quality Assurance & Compliance role involves leading the pre-clinical, clinical, medical, and pharmacovigilance quality assurance and compliance program. The ideal candidate should have a Bachelor's Degree in a relevant scientific discipline, pharmaceutical industry experience, and expert knowledge in US and EU ICH/GCP, SOPs, and local regulatory requirements.
Director, Marketing
Company: Corcept Therapeutics
Location: Peninsula
Posted Apr 29, 2024
Corcept is a leading company in the research and development of cortisol modulators, with over 1,000 proprietary molecules discovered. They received FDA approval for Korlym® (mifepristone) in 2012, the first treatment for hypercortisolism (Cushing syndrome). Currently, they have more than 30 ongoing studies across various disease areas, including endocrinology, oncology, metabolism, and neurology. They are seeking an experienced Director of Marketing to lead their marketing efforts for an emerging therapeutic area, focusing on ALS. The role involves developing and executing a strategic marketing plan, building relationships with patient advocacy groups and healthcare professionals, and ensuring legal/regulatory compliance of marketing materials.
Senior Data Scientist
Company: Kyverna Therapeutics
Location: Other US Location
Posted Apr 29, 2024
Kyverna Therapeutics is seeking a data scientist or bioinformatics engineer to join their team. The role involves working with a multidisciplinary team to integrate and analyze high-dimensional data from various sources, including clinical trials, individual patient use, and CAR-T development and manufacturing. The candidate will build and maintain dashboards for data visualization and analysis, ensure product quality, and collaborate with the Translation group to understand the mechanism of action. The ideal candidate should have a degree in a relevant field, 5+ years of experience in biotech/pharma, strong programming skills in R/Shiny, Python, JavaScript, and Tableau, and experience in multivariate data analysis. The salary range is $150,000 - $200,000 annually.
Associate Director, HR Operations
Company: Dyne Therapeutics
Location: Waltham
Posted Apr 30, 2024
Dyne Therapeutics is seeking an Associate Director of HR Operations for their Waltham, MA office. The role involves overseeing HR operations, developing policies, managing vendor relationships, and ensuring compliance with employment laws. The ideal candidate will have a Bachelor's degree in HR or related field, a Master's degree preferred, and 8+ years of HR operations experience. Knowledge of HR best practices, employment laws, and regulatory requirements is essential. Strong communication, interpersonal, and leadership skills are required, along with SHRM-CP or SHRM-SCP certification. The role offers opportunities for strategic HR initiatives and driving business objectives.
Sr. Research Associate, Potency Assays
Company: 4D Molecular Therapeutics - (4DMT)
Location: Other US Location
Posted Apr 29, 2024
<div> <p><strong><em>Attention recruitment agencies<em><strong><em> All agency inquiries are vetted through 4DMTs internal Talent Acquisition team No unsolicited resumes will be accepted Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future<em><p> <p><br ><p><p>4DMT is a clinicalstage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines We seek to unlock the full potential of gene therapy using our platform Therapeutic Vector Evolution TVE which combines the power of directed evolution with our approximately one billion synthetic AAV capsidderived sequences to invent evolved vectors for use in our products We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles These profiles will allow us to treat a broad range of large market diseases unlike most current genetic medicines that generally focus on rare or small market diseases <p> <p>We have built a deep portfolio of AVVbased gene therapy product candidates with five product candidates in clinical trials 4D150 for the treatment of wet agerelated macular degeneration wet AMD and diabetic macular edema DME 4D710 for the treatment of cystic fibrosis lung disease 4D310 for the treatment of Fabry disease cardiomyopathy 4D125 for the treatment of Xlinked retinitis pigmentosa XLRP and 4D110 for the treatment of choroideremia In addition we have two product candidates in preclinical studies 4D175 for geographic atrophy GA and 4D725 for alpha1 antitrypsin deficiency<p> <p>Todate we have demonstrated clinical proofofconcept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors We have built a robust and efficient product engine with 6 open Investigational New Drug Applications INDs in the US 1 IND in Taiwan and 1 Clinical Trial Approval CTA in Australia We believe we are positioned to create develop manufacture and if approved effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases<p> <p>In addition to TVE our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material This internal capability and close collaboration between our RampD and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT<p> <p>Company Differentiators <p> <p> Fully integrated clinicalphase company with internal manufacturing<br > Demonstrated ability to move rapidly from idea to IND<br > Five candidate products in the clinic and two declared preclinical programs<br > Robust technology and IP foundation including our TVE and manufacturing platforms<br > Initial product safety and efficacy data substantiates the value of our platforms<br > Opportunities to expand to other indications and modalities within genetic medicine<p> <div> <p><span datacontrast=auto>Senior Research Associate will primarily focus on executing routine cellbased testing as per approved SOPs QCfocused for lot releasestability comparability and formulation assessment of drug substances and drug products in accordance with cGMP standards and contribute to develop optimize and validate new cellbased assays drafting SOPs and data analysis This role will interface with Research Discovery Process Development Manufacturing Quality and Facilities functional groups as well as external parties CRO CDMO to support life cycle of bioassays for current and new candidates during early and latestage GMP production This is a fulltime and onsite position in the CMC department reporting to the Senior Manager of Cellbased Assays team<span><span dataccpprops=> <span><p> <p><span datacontrast=auto>RESPONSIBILITIES <span><span dataccpprops=> <span><p> <p><strong><span datacontrast=auto>BenchworkDocumentationResults analysis 60 of the TIME<span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>Maintain cell lines prepare and qualify cell banks using aseptic techniques with emphasis on adherent mammalian cell culture systems<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Develop optimize and execute bioassays including cellbased nucleic acidbased ELISA and enzymatic assays with a strong scientific understanding of the analytical procedures and applicability of the emerging or existing assay platforms<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Understand phaseappropriate GMP requirements for AAVbased gene therapy products<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Performs routine testing of samples for characterization Process Development support and QC releasestability purposes under limited supervision<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Provide feedback andor suggest modifications to operational procedures<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Assist with troubleshooting of analytical procedures and equipment problems work with Facilities to assist with calibration maintenance and operation requirements of analytical equipment<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=11 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Assist with the new facility expansion and equipment validation activities as needed<span><span dataccpprops=> <span><li> <ul><p><strong><span datacontrast=auto>PaperworkDocumentation 40 of TIME<span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>Complete and submit experimental records following Good Documentation Practices cGMP guidelines and corporate policies to meet both operational and compliance requirements<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Compiles Results from executed experiments and analyses and presents data to the manager CBA team or in crossfunctional meetings as needed<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=auto>Contribute to experimental protocols reports internal documents including SOPs lab records deviations and investigations as appropriate<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=auto>Help with maintenance of lab inventories and database for designated projects<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=auto>Work closely with supervisors and crossfunctional teams for setting up and following the testing schedule to meet timelines for products release stability and characterization purposes<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=auto>Work closely with team to keep the reagents and lab supplies inventory stocked properly and within expiration<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=12 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=auto>Follow all Quality and Safety procedures including deviation and nonconformance reporting Support deviation investigations and lab maintenance<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=auto>Manages equipment PMs change controls and equipment calibration documentation<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=10 datalistdefnprops= dataariaposinset=16 dataarialevel=1><span datacontrast=auto>Support implementation of new Laboratory Information Management System LIMS<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=17 dataarialevel=1><span datacontrast=auto>Other duties as assigned <span><span datacontrast=auto>nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time<span><span dataccpprops=> <span><li> <ul><p><span datacontrast=auto>QUALIFICATIONS<span><span dataccpprops=> <span><p> <p><span datacontrast=auto>Education<span><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=5 datalistdefnprops= dataariaposinset=1 dataarialevel=1><span datacontrast=auto>MS degree in Biochemistry CellMolecular Biology or related area of life sciences with 3+ years of experience in cellbased bioassays or BS degree with 5+ years of experience in the pharmaceutical industry desired<span><span dataccpprops=> <span><li> <ul><p><span dataccpprops=> <span><p> <p><strong><span datacontrast=auto>Required Skills<span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=2 dataarialevel=1><span datacontrast=auto>Proficiency with mammalian CellTissue culturing and aseptic techniques<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=3 dataarialevel=1><span datacontrast=auto>Handson experience in virus transduction and plasmid transfection of cells and troubleshooting<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=13 datalistdefnprops= dataariaposinset=4 dataarialevel=1><span datacontrast=auto>Handson experience and strong understanding of the technical concepts in immunoassays Western Blotting ELISA and techniques such as ddPCR<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=14 datalistdefnprops= dataariaposinset=5 dataarialevel=1><span datacontrast=auto>Attention to detail quality and compliance with strict adherence to test procedures and protocols<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=15 datalistdefnprops= dataariaposinset=6 dataarialevel=1><span datacontrast=auto>Ability to learn new technologies and processes in a timely manner<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=16 datalistdefnprops= dataariaposinset=7 dataarialevel=1><span datacontrast=auto>Must be a team player with an analytical mindset a detailoriented critical thinker and exhibit a readiness to meet project timelines and challenges in a dynamic fastpaced environment<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=17 datalistdefnprops= dataariaposinset=8 dataarialevel=1><span datacontrast=auto>Strong written and oral communication skills with demonstrated ability to present scientific ideas information and data effectively via oneonone discussions and team meetings<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=17 datalistdefnprops= dataariaposinset=9 dataarialevel=1><span datacontrast=auto>Basic math and familiarity with Excel Word and PowerPoint<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=17 datalistdefnprops= dataariaposinset=10 dataarialevel=1><span datacontrast=auto>Ability to work independently and work with others in designing and developing experiments analyzing and interpreting data<span><span dataccpprops=> <span><li> <ul><p><strong><span datacontrast=auto>Preferred Skills<span><strong><span dataccpprops=> <span><p> <ul><li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=11 dataarialevel=1><span datacontrast=auto>Cellbased potency assay experience in the ADQC environment<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=12 dataarialevel=1><span datacontrast=auto>Handson experience with SDSPageWestern Blot proteinprotein interactions and flow cytometry<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=13 dataarialevel=1><span datacontrast=auto>Experience in the development of new methods and sound scientific understanding of Quality by Design QbD and Design of Experiments DoE principles as well as data analysis and statistics<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=14 dataarialevel=1><span datacontrast=auto>Experience with bioassay andor statistical software such as SoftMax Pro PLA GraphPad Minitab JMP or Spotfire<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=auto>Working knowledge of regulatory and industry guidelines in CMC analytical development<span><span dataccpprops=> <span><li> <li dataleveltext= datafont=Symbol datalistid=7 datalistdefnprops= dataariaposinset=15 dataarialevel=1><span datacontrast=auto>General understanding of compendial testing ICH qualificationvalidation<span><span dataccpprops=> <span><li> <ul><p><u>BASE SALARY COMPENSATION RANGE<u><p> <p><span dataccpprops=>Bay Areabased candidates $104000yr $125000yr<span><p> <p><br ><br ><br ><p><p><span dataccpprops=> <span><p> <div> <p>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws<p> <p> <p> <p>Equal Opportunity EmployerProtected VeteransIndividuals with Disabilities<p> <div>
Director, Human Resources
Company: Corcept Therapeutics
Location: Peninsula
Posted Apr 29, 2024
Corcept is a company that is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor. They have discovered over 1,000 selective proprietary cortisol modulators and are working on various studies to treat serious diseases.
Bioanalytical Scientist
Company: Alloy Therapeutics, Inc.
Location: Waltham
Posted Apr 30, 2024
<p><strong>The Company<strong> <p> <p>We are Alloy Therapeuticsa biotechnology ecosystem company empowering the global scientific community to make better medicines together Through a community of partners we democratize access to precompetitive tools technologies services and company creation capabilities that are foundational for discovering and developing therapeutic biologics The company facilitates affordable nonexclusive access to the entire drug discovery community from academic scientists small and medium biotech to the largest biopharma At Alloy we believe our industry should compete on getting the best drugs to patients as quickly as possible not exclusive access to the best platforms As a reflection of our relentless commitment to the scientific community we reinvest 100 of our revenue in innovation and access to innovation MAY THE BEST DRUG WIN <p> <p>Alloy is headquartered in Waltham MA with additional labs in Cambridge UK Basel CH and Athens GA and 82VS portfolio companies in Boston San Francisco Dallas and Oklahoma City Successful members thrive in our shared culture of accountability deliberate trust and open communication As a team we aspire to work together to exceed expectations and collectively contribute across the global organization to always maintain our nimble startup culture <p> <p>This is an onsite and fulltime position with flexibility to work from home At Alloy we have an ethos of MentorshipByApprenticeship in all of our positions We strive to have workers in the office when needed to interact organically and facetoface Of course as a labbased operation our cells and animals grow 7 days a week 365 days per year We respect and value our colleagues for their hard work that requires them to be in the lab every day We ask our people who have more flexible accommodations like this position to appreciate their colleagues who have less flexibility We are all one team <p> <p><strong>The Team<strong> <p> <p>The Alloy Global Bioanalytics group provides bioanalytical support to all Alloy activities including assay development quality control and highthroughput characterization of antibodies TCRs TCR mimics and <p> <p>other modalities <p> <p><strong>The Role<strong> <p> <p>As a Scientist you will work with our Discovery Services team to support the discovery of antibodybased therapeutics You will be using the very latest protein analytics tools and protocols with the ultimate goal of helping others to make better medicines This role requires an enthusiasm for biochemical and biophysical characterization of antibodies including bispecific and multispeicfic antibodies <p> <p>This role will report to our Senior Director of Global Bioanalytics with autonomy owning various stakeholders projects and tasks in a dynamic startup environment while keeping up the pace of Alloy This is you <p> <p><strong>How Youll Drive Impact<strong> <p><ul><li><strong>Drive <strong>Perform biochemicalbiophysical characterization eg protein purity aggregation charge variance binding characterization eg proteinprotein interactions cell binding ligand inhibition assays andor developability assessment eg thermostability selfinteraction polyreactivity<li> <li><strong>Deliver <strong>Achieve efficient execution of partner projects maintain a balance between quality timeline and cost thereby ensure successful project delivery <li> <li><strong>Support <strong>Contribute and promote an inclusive and collaborative work environment<li> <li><strong>Innovate<strong> Look for new ideas assays or tools for analytical evaluation of discovery outcome<li> <li><strong>Collaborate<strong> Work closely with crossfunctional teams spanning all Alloy locations<li> <ul><p><strong>Why We Value You<strong> <p><ul><li>You have a PhD degree in a relevant scientific field eg Biochemistry Biotechnology Biology and have experience with antibody discovery and development<li> <li>You have an indepth knowledge of current stateoftheart biochemical and biophysical characterization of antibodies display a strong command of the fundamental principles of analytical chemistry <li> <li>You have experience with Flow Cytometry SPR or BLI SEC HPLC<li> <li>You have experience with protein labeling including biotinylating and fluorophore labeling<li> <li>You have a track record of troubleshooting instruments<li> <li>You have excellent written and oral communication skills<li> <li>You can multitask and accomplish goals under project and team timelines<li> <li>You have an independent sense of urgency persistence and integrity<li> <li>Attention to detail Rigorous and innovative scientific thinking <li> <li>You have ELN and LIMS experience <li> <ul><p><strong>Desired Multipliers<strong> <p><ul><li>You have experience with protein characterization by using LCMSMS<li> <li>Ability to work across various US and international time zones <li> <li>Accommodate occasional travel as needed <li><ul><p><b>Taking Care of Our People<b> <p> <p>We support the individuality of what people need to do outside of work to empower them to do their best at work While you focus on making better medicine together we focus on programs and benefits that support a diverse and growing team Whether youre single in a growing family or nearing retirement Alloy offers a variety of comprehensive and competitive benefits starting from day one <p> <p>Compensation <p><ul><li>Competitive base and equity compensation commensurate with level of experience and independence<li> <li>401k company match<li> <ul><p>Health amp Family <p><ul><li>Generous personal and family medical dental and vision benefits with 100 of premiums and deductibles covered<li> <li>Companypaid disability STD LTD and life insurance<li> <li>Paid parental leave<li> <li>Family planning support up to $45000 eg IVFPGT adoption surrogacy egg retrieval<li> <ul><p>Unique Perks <p><ul><li>Unlimited PTO paid time off and flexible schedules<li> <li>Annual stipend for continuing education with commitment to your career through individualized professional development plan<li> <li>Wellness and Extensive Employee Assistance Program EAP including resources for mental wellness<li> <ul><p><strong>Diversity Equity and Inclusion<strong> <p> <p>Here at Alloy we democratize capabilities for discovering and developing therapeutic biologics So being diverse and inclusive isnt just something we strive for it is who we are and part of what we do each and every single day We want to ensure that as an employee you feel Alloy is a place where no matter who you are you feel safe included and that you have the opportunity to bring your unique self to work <p> <p>Alloy Therapeutics is an equal opportunity employer All qualified applicants will receive consideration for employment without regard to race color religion national origin sex sexual orientation gender identity veteran status disability or other legally protected status If you are unable to submit an application because of incompatible assistive technology or a disability please contact us at email protected We will make every effort to respond to your request for disability assistance as soon as possible<p>