This role collaborates closely with regional Product Strategy and OEM teams to drive innovation in product concepts and performance claims, while conducting performance and quality testing to support formulation approvals and renewals. You'll also manage documentation for industry and OEM specifications, support blending plant operations through production and new product introduction, and provide leadership to scientists by guiding project execution, ensuring safety compliance, and fostering professional development.

Responsibilities include:

• Working with a Safety First mindset
• Leading the formulation development of new EV lubricant fluids, including those for hybrid transmissions and battery electric vehicles
• Understanding the mechanical requirements of EV hardware and applications to formulate products to meet the needs of an EV lubricant
• Assisting in the development of new Driveline lubricant fluids for China region, including those for light-duty and heavy-duty transmissions, gear oils, and transfer cases
• Presenting data and claims of Valvoline products to technical and engineering teams during customer meetings in support of the Valvoline OEM team
• Designing and managing novel testing protocols to validate new product formulations in support of differentiated claims, product licensing, OEM approvals, and regulatory compliance
• Supporting Product Strategy, Sales, Marketing, Key Accounts, and Customer Care by delivering technical expertise, product training, and guidance on performance claims
• Leading a team of scientists, ensuring safety compliance while providing direction and mentorship to support successful project execution and career growth
• Providing technical support to Valvoline's blending plants, including production troubleshooting, new product introductions, and updates to quality specifications

To succeed in this role, you'll need:

• A minimum B.S. in Chemistry or Engineering Discipline with direct experience
• A Master's or Doctorate in Tribology, Mechanical Engineering, Chemistry, or Automotive/Materials Engineering preferred
• Experience formulating finished lubricants, either for an oil marketer, additive supplier, or base oil manufacturer
• Knowledge of transmission, gear, and EV specifications and qualification procedures is advantageous
• Experience with analytical test methods and laboratory methods is beneficial, especially surface evaluation such as SEM
• Ability to organize and manage complex projects and work with tight deadlines
• Knowledge of the lubricant market, including competitors and product landscape
• Collaborative skills to advance projects both internally and externally
• Strong communication/presentation skills
• Computer Skills - specifically Outlook, Excel, PowerPoint, SAP, and QC software
• Statistical methods and design of experiments
• People management with a focus on empowerment and development

Working Conditions/Physical Requirements: Ability to lift up to 50 pounds. Travel Requirements: Up to 20% travel requirement, some international travel.

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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.

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