The Director, Manufacturing Science and Technology should be passionate about organizing ideas, logistics, and technical details to support establishing and leading robust product development and manufacturing efforts at the company. This role requires leadership to direct team efforts up to and including performing pilot-scale manufacturing at Lindy to meet biopharmaceutical client needs. This role reports directly to the COO and will work closely with senior company leadership and department leads at the company. Externally, the Director, Manufacturing Science and Technology will collaborate closely with our biopharmaceutical clients and CDMO partner. The position is at the Lindy facility in Morrisville, NC, and will be a key part of the technical operations team at the company.

Key Responsibilities & Technical Skills

·      Lead and Manage the Technical Operations Team: Understand formulations, analytical development, equipment selection, stability profiles, and the roles these have in robust product manufacturing programs. Ensure all formulation and manufacturing activities incorporate these elements as necessary.

·      Cross-Functional Coordination: Work with R&D, Analytical Services, Project Management, Formulation Development, and Manufacturing teams. Collaborate with cross-functional teams internally and CDMO externally on process development and manufacturing-related issues to resolve problems.

·      Manufacturing at Lindy: Direct and plan all production for formulation development batches, lead pilot-scale, and manufacture of GLP batches for partner companies as necessary.

·      Analytics and Process Optimization: Drive the compilation of data and use of performance metrics from cumulative batch processing to determine trends for monitoring quality and identifying process improvements.

·      Technology Transfer: Manage ongoing technology transfer and process validation from Lindy to the CDMO; ensure comparability with internal pilot-scale manufacturing.

·      Scale-up Support/Oversight: Review CDMO statements of work (SOW) and ensure that internal Lindy pilot-scale manufacturing efforts support all technology transfer to and scale-up at CDMO.

·      Risk Mitigation & Problem Solving: Identify technical and logistical risks, proactively solve issues, and implement corrective actions to optimize manufacturing operations.

·      Logistics Oversight: Ensure all materials, equipment, documentation, and required facility support is identified and correct for performing manufacturing operations in a reliable and reproducible manner.

Competencies/Essential Skills

• Technical Formulations Expertise: proven track record leading successful manufacturing operations and teams for protein formulations in complex formulations.

·       Manufacturing Expertise: experience establishing production schedules and development timelines per applicable product quality standards.

• Serve as process owner, plan to avoid delays, and lead activities to ensure a robust and effective product and manufacturing process against development timelines.

• Oversee stability studies as required for product formulation selection.

• Guide root-cause analysis for process issues and ensure manufacturing precision.

• Compliance knowledge: proficiency in cGMP manufacturing environments, including familiarity with cGMP manufacturing regulations for aseptic fill/finish products.

• Operational Excellence: drive continuous improvement initiatives across manufacturing processes, equipment utilization, and operational workflows to enhance productivity and reduce cost during manufacturing product development and tech transfer/scale-up activities. Lead efforts to address technical challenges as necessary.

• Development/Manufacturing Bridge: support process development and transfers from R&D/pilot-scale to clinical production, including establishment of risk and mitigation strategies. Establish robust batch records and manufacturing processes based on Lindy technology, engineering, and development activities.

• CMC Sub-team and Project Leadership: demonstrate experience leading cross-functional sub-teams (w/SMEs for formulation, and manufacturing process development and scale-up from pilot scale to full clinical phase production). Must be proficient in using software tools (Smartsheet, SharePoint, etc.) for documentation and execution management.

  • Serve as a key scientific and technical representative for manufacturing process-related activities for batches produced at Lindy. Review and provide feedback on project deliverables and offer technical/scientific support.

Minimum Required Education and/or Experience

·      M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field, with at least 8 years of experience in pharmaceutical manufacturing; or a B.S. degree with 10 years of experience in the same field.

·      Proven ability to effectively lead complex projects and participate in teams. Minimum 3 years supervisory experience.

·      Excellent oral and written communication skills.

·      Experience in senior manufacturing or development operations roles within a biopharmaceutical GMP manufacturing environment, including experience with formulation and aseptic fill/finish.

·      Familiarity with cGMP manufacturing regulations for aseptic fill/finish products and associated validation/qualification requirements.

·      Expertise leading manufacturing teams through development and into pilot scale manufacturing for formulation development/selection and stability profile support.

·      Expertise in aqueous phase chemical formulations, including experience with a variety of solvents.

Supervisory Responsibilities

Ability to direct and lead team members in their respective department. The need to supervise will be dependent on company needs.

Travel

Occasional travel to CDMO or client facilities.

Affirmative Action/EEO statement 

Lindy Biosciences is an equal employment opportunity employer and does not discriminate against any person because of race, color, creed, religion, national origin, political affiliation, sex, gender identity or expression, sexual orientation, age, disability, genetic information, or other reasons prohibited by law (referred to as "protected status"). This nondiscrimination and opportunity policy extends to all employment actions such as promotions, compensation, benefits and termination of employment.

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.