Lead Scientist

Lead Scientist, Microbiology

The Position

The Microbiology and Environmental Monitoring groups at Catalent Morrisville are responsible for the microbial testing support for internal and external customers including Catalent sister sites. The microbiology team performs microbiology testing (sterility, microbial limits, endotoxin testing, etc.) for API, Finished Product, Stability, Raw Materials and Components. The Environmental Monitoring team performs microbiology testing (TOC, conductivity, bioburden, etc.) supporting onsite utilities and manufacturing environments.

The Lead Scientist, Microbiology works with minimum supervision, conferring with superior on unusual matters. This position is usually assisted by laboratory technicians/associates. This role demonstrates potential for technical proficiency and scientific creativity through broad assignments. The Lead Scientist has appreciable latitude for unreviewed action or decision. The Lead Scientist, Microbiology may be responsible for setting and defining technical objectives and assessing results. Comply with divisional and site Environmental Health and Safety requirements.

The Role

• Develop and execute laboratory work plans for self and junior members of team, using customer milestones and site standards and metrics.
• Authors and may approve technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures.
• Review technical documents for accuracy, thoroughness and regulatory compliance.
• Train, coach, or mentor others on technical, personal development or business issues.
• Supervise technical staff, including work assignments and performance management.
• Responsible as Project Director on one or more projects, with responsibility for project outcome and customer interaction.
• Develop and execute efficiency improvement projects.
• Identify and recommend business opportunities on project specific basis.
• All other duties as assigned.

The Candidate

• Doctoral degree, master's degree, or bachelor's degree in chemistry or closely related physical science from a 4-year college/university or equivalent education and job experience.
• Ph.D. and 2-5 years related experience, MS and 6-9 years related experience, BS and 9-12 years related experience.
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability to learn and retain technical information Internal expert on data interpretation, applications, instrumentation and theory in at least one area of expertise.
• Consistently provides accurate data within the framework of regulatory guidance.
• Evaluate and assess impact of proposed changes to controlled documents and/or project scope.
• Able to combine and interpret data from multiple disciplines for a project.
• Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization.
• Propose deviations from established procedures and methods based upon sound judgment.
• Excellent written and verbal communications skills with internal and external customers.
• Ability to communicate basic technical information to non-technical audiences.
• Leadership development/ supervisory skills are expected.
• Can assess new technologies and their impact on Catalent offerings.
• Lead by example according to Catalent's values and culture.
• Can assess training needs and formulate development plans for subordinates.
• Based on broad technical skills and drug development experience, anticipates and identifies unmet customer needs.
• Ability to interpret and provide variety of instruction furnished in written, oral, diagram, or schedule form Understand elements of a regulatory CMC filing package and the analytical documentation required therein.
• Well organized with ability to multitask.
• Ability to work effectively under pressure to meet deadlines.
• May publish or present externally.
• On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds.
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.
• May require the use of a respirator.
• This position will be stationed in an office and laboratory environment involving work near moving/mechanical parts; working around various chemicals including biologics, active pharmaceuticals, beta-lactams and radioactive materials; and other conditions reasonably expected due to the nature of the work required.
• Position may require domestic or international travel.
• Flexibility required to work outside normal working hours of 8:00 a.m. - 5:00 p.m.

Why You Should Work At Catalent

• Spearhead exciting and innovative projects
• Fast-paced, dynamic environment
• High visibility to members at all levels of the organization
• 152 hours of PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

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