Senior Manager, Drug Product Manufacturing Science - Waltham, United States - Apellis

Description

Job Description

Position Summary:

As part of the MSAT team, the Senior Manager of Drug Product Manufacturing Science and Technology, will manage tech transfer and process validation at contract drug product manufacturing sites. The Senior Manager of Drug Product MSAT is responsible for drug product process tech-transfer, scale-up, PPQ, and monitoring and optimization of the manufacturing process for the vial and/or pre-filled syringe drug product configurations. The incumbent will bring extensive technical expertise in drug product manufacturing as related late-stage and commercial programs. The position will provide technical support to Drug Product Manufacturing and lead a variety of late-stage lifecycle programs.

Key Responsibilities Include:

• Manage tech transfers, scale-up, and process validation (PPQ) for drug product manufacturing processes for existing late-stage/commercial drug product programs at new manufacturing sites/lines as part of product lifecycle management and lead the start-up of new product lines for clinical programs from Phase 2.
• Gather knowledge, develop and implement strategies for tech-transfer, scale-up and PPQ with emphasis on adequate process controls, risk mitigation and suitability for regulatory filings.
• Bring deep technical expertise in areas such as aseptic processing, PPQ strategy, filter validation, PUPSIT, etc.
• Apply risk management principles and methodologies throughout lifecycle management including FMEA, gap analysis, etc.
• Ensure manufacturing processes, facilities, equipment, raw materials and cleaning methods are validated and maintained in a state of compliance with all cGMP and global health regulations.
• Partner with cross-functional stakeholders (PM, QC, QA, Supply Chain and Regulatory) as needed to enable tech transfers and PPQ campaigns.
• Participate as an integral project member of internal or external projects (process implementation, validation, and tech transfers) as a drug product MSAT technical expert.
• Manage development, tech-transfer and validation activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
• Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
• Confirm equipment qualification as a part of the process validation process (e.g. correct installation, efficient operation, robust performance).
• Assess opportunities for continuous improvement of the manufacturing processes based on trend analysis, advances in manufacturing technology and controls and new industry standards.
• Support evaluation of major deviations, root-cause-analysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance.
• Develop process for management of data and analysis of various operational parameters, including Annual Product Review (APR) and Continuous Process Verification (CPV).
• Participate in the active writing and review of CMC Module 3 sections for regulatory submissions (NDA, PAS, etc.).

Education, Registration & Certification:

• College degree in life sciences / engineering or in a related area. Advanced degree (MS or PhD) preferred.

Experience:

• 6-7 years of progressive work experience in cGMP development & drug product manufacturing with a strong scientific and technical background with experience in drug product MSAT.

Skills, Knowledge & Abilities:

• Extensive knowledge in the field of drug product manufacturing processes, technology, and systems with prior experience in the areas of process development, tech-transfer, scale-up and validation.
• Prior experience with isolators for aseptic processing and statistical analysis of data using software such as JMP is desired.
• Experience with CMC Module 3 authorship with working knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for cGMP operations.
• Attention to detail and a hands-on approach towards project management tasks such as compilation of data, reports and presentations, dashboards and budget tracking.
• Excellent technical computer skills, communication, comprehension, interpretation, problem-solving, team spirit, critical thinking and organization skills.
• Demonstrated ability to work effectively in a team environment with the ability to effectively manage and build great relationships with external and internal collaborators.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more Visit to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.