Pharm Tech Scientist

Job Title: Pharm Tech Scientist

Department: Pharmaceutical Technology

Reporting To: Sr. Manager, Pharmaceutical Technology

Classification: Exempt

Pay Range:72k-99k

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in San Diego, CA. Our 10 facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

The Pharm Tech Scientist, under direct supervision, performs various duties related to optimization and analysis of production processes, new products, commercial process support and new product technology transfers.

• Pharm tech duties within a single site.
• Make decisions within guidelines and policies.
• Use established procedures to perform assigned tasks. Ask for guidance from other colleagues.
• Work is reviewed by higher level staff members or management.
• Work is measured by output, meeting and achieving pre-defined quarterly goals and 1-2 week targets based on timelines established with clients.

Essential Functions and Responsibilities

• Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.
• Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, AR&D, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new
• Assist with on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
• Assist with formulation development and evaluation for marketed and new products.
• Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
• Support investigations on deviations.
• Evaluate and troubleshoot basic manufacturing / packaging equipment and process issues.
• Works on problems of limited, defined scope. Is able to learn how the value of following established practices and procedures in analyzing basic situations or data from which answers can be readily obtained.
• May conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.
• Interact daily with team members and/or functional peer groups, other teams/depts.

Requirements

• BS degree in Engineering or Chemical Engineering preferred with 0-3 years' pharmaceutical or related experience.
• Experience with Hot Melt Extrusion and Spray Drying
• Internal candidates with 5+ years' experience at a Senior Technician level may be considered.
• Basic knowledge of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
• Basic understanding of concepts of equipment qualification.
• Basic understanding of computer validation concepts.
• Basic statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
• Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
• Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.
• Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.
• The noise level in the work environment is usually moderate

Preferred Qualifications

• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.

Benefits

BioDuro-Sundia employment provides the opportunity to work in beautiful Irvine, California. We offer a competitive package to our employees. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing [email protected]. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.