The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization).

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• Lead drug product manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.

• Serve as the primary technical interface with CDMOs and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.

• Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.

• Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues

• Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.

• Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug product for clinical trials and commercial supply.

• Lead technical assessments and qualification of new CDMOs for drug product manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.

• Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.

• Partner closely with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.

• Collaborate with procurement to ensure timely contracting for drug product manufacturing.

About You

• MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.

• 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.

• Demonstrated track record of successfully managing drug product manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.

• Technical expertise in aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.

• Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

• Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.

• Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.

• Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.

• Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.

• Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Total Compensation Range

$177,000 - $235,000

Where We Hire

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.

XML job scraping automation by YubHub

Product Manufacturing Engineer

Location

San Francisco

Employment Type

Full time

Department

Scaling

Compensation

• $123K – $285K • Offers Equity

The base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If the role is non-exempt, overtime pay will be provided consistent with applicable laws. In addition to the salary range listed above, total compensation also includes generous equity, performance-related bonus(es) for eligible employees, and the following benefits.

• Medical, dental, and vision insurance for you and your family, with employer contributions to Health Savings Accounts

• Pre-tax accounts for Health FSA, Dependent Care FSA, and commuter expenses (parking and transit)

• 401(k) retirement plan with employer match

• Paid parental leave (up to 24 weeks for birth parents and 20 weeks for non-birthing parents), plus paid medical and caregiver leave (up to 8 weeks)

• Paid time off: flexible PTO for exempt employees and up to 15 days annually for non-exempt employees

• 13+ paid company holidays, and multiple paid coordinated company office closures throughout the year for focus and recharge, plus paid sick or safe time (1 hour per 30 hours worked, or more, as required by applicable state or local law)

• Mental health and wellness support

• Employer-paid basic life and disability coverage

• Annual learning and development stipend to fuel your professional growth

• Daily meals in our offices, and meal delivery credits as eligible

• Relocation support for eligible employees

• Additional taxable fringe benefits, such as charitable donation matching and wellness stipends, may also be provided.

More details about our benefits are available to candidates during the hiring process.

This role is at-will and OpenAI reserves the right to modify base pay and other compensation components at any time based on individual performance, team or company results, or market conditions.

About the Team

The Compute team works on the design of our AI supercomputers, doing everything from workload modeling to influencing accelerator design. We’re leaning into our partnerships to make system and data center co-design an integral part of this process, and are looking for engineers to design AI supercomputers solutions for data center applications

This team will be responsible for working with partners to optimize their hardware for our workloads, identifying promising new deep learning accelerators, and bringing those hardware platforms to production.

If you’re excited to work at the intersection of cutting edge deep learning, hardware system, and data center design this role is for you!

About the Role

We’re looking for a product manufacturing engineer, who will be responsible for driving technical initiatives related to manufacturing to ensure product success from concept to launch and through mass production with a specific focus on PCB and PCBa manufacturing and process. You’ll have the opportunity to work with a wide range of stakeholders, from design engineering and operations teams, TPMs, external industry vendors and partners to ensure that all products are developed and delivered on time and to the highest quality standards.

This role is based in San Francisco, CA. We use a hybrid work model of 3 days in the office per week and offer relocation assistance to new employees.

In this role, you will:

• In this role, you’ll be responsible for driving manufacturing and quality initiatives to ensure product success from concept to launch

• Lead the product design and the manufacturing process for next-gen AI hardware system development, you will have the opportunity to work with a wide range of stakeholders, from design engineering and operations teams, TPMs and external industry vendors and partners to ensure that all products are developed and delivered on time and to the highest quality standards.

• Lead the team to establish NPI product manufacturing process, systems and quality controls, defining clear milestones and deliverables, drive internal process improvements across multiple terms and functions

• Provide hands-on product manufacturing analysis during design, development, testing, prototypes and production phases.

• Research automation techniques and develop new tests and systems for efficiency.

• Own L6 up to potentially L10 product manufacturing development of the hardware product. This includes the PCB, PCBA, cabling and connectorization & L10 assembly spanning internal and external development work through successful deployment into the infrastructure and support of production workloads at scale

• Develop and manage overall product manufacturing requirements, scope, schedules, and deliverables with engineering teams, TPMs, suppliers, partners and key stakeholders

• Communicate effectively with cross-functional teams to ensure successful execution of programs

• Utilize problem-solving skills to resolve issues and overcome obstacles, perform risk assessment, risk mitigation and change management on projects.

• Manage multiple projects simultaneously

• Monitor project progress and ensure deadlines and standards are met

You might thrive in this role if you:

• Have an impressive track record of leading complex projects from concept to production launch and have the ability to work with cross-functional teams to ensure successful execution of programs

• Are a creative, detail-oriented, and self-motivated individual looking for an exciting opportunity in the tech industry, this could be the perfect role for you

• Stay up to date on industry trends and manufacturing technologies for PCB & PCBa

• Like being a close partner with cross-functional teams to understand key design changes requiring validation to accurately integrate engineering validation needs into the overall system bu

XML job scraping automation by YubHub