Careers

Alliance Project Manager

Lindy Biosciences is solving critical formulation challenges in the biotherapeutics market through our Microglassification™ technology. Our platform produces high-dose suspensions of therapeutic proteins suitable for subcutaneous injection — a formulation approach that reduces administration costs, improves patient comfort and compliance, and enables a new class of high-dose molecules to reach patients.

We have a dedicated team of unique thinkers and problem-solvers. As a small company, every employee has a tremendous impact on our success, and we have abundant opportunity to learn, innovate, and challenge each other. We are passionate about improving our knowledge, skills, products, and ultimately improving the drug delivery experience for patients. 

The Alliance Project Manager should be passionate about organizing ideas, logistics, technical details, and driving collaborative product development. This role is the bridge between biopharmaceutical client needs and scientific execution, overseeing complex pharmaceutical projects for partner programs from development to commercial manufacturing. This role involves oversight of process improvements, regulatory compliance, and technical leadership in development and manufacturing. The Alliance Project Manager will work closely with senior leadership and department leads, acting as a point of integration across the team. Externally, the Alliance Project Manager will collaborate closely with our biopharmaceutical clients and manufacturing partner.

Key Responsibilities & Technical Skills:

• Project Life Cycle Management: Managing projects from early-phase development through clinical and commercial production at a CDMO.

• Technical Knowledge: Understanding formulation, analytical development, manufacturing processes, and stability studies.

• Technology Transfer: Leading the transfer of processes from Lindy Biosciences to the CDMO facility.

• Risk Mitigation & Problem Solving: Identifying technical and logistical risks, proactively solving issues, and implementing corrective actions.

Key CDMO Experience Requirements:

• Cross-Functional Coordination:  Working with R&D, QA, Analytical Services, Supply Chain, and Manufacturing teams.

• Client Management: Acting as the primary point of contact, ensuring client satisfaction and clear communication.

• Contractual Oversight: Reviewing Statements of Work (SOW), managing project scope, timelines, budget, and controlling change orders.

Competencies/Essential Skills:

• Technical Expertise: Proven track record of leading successful manufacturing operations and teams for protein formulations, development, and manufacturing.

• Development/Manufacturing Bridge: Ability to support process development & transfers from R&D/pilot-scale to clinical production, including establishment of risk and mitigation strategies.

• CMC Sub-team Project Management Leadership: Demonstrated experience leading cross-functional sub-teams (w/SMEs for formulation, process, and analytical development) and managing internal and external stakeholders like CDMOs. Must be extremely proficient in using software tools (Smartsheet, SharePoint, etc.) for project management and execution management.

  • Serve as a key scientific and technical representative for process-related issues at internal sites and with external partners. Review and provide feedback on project deliverables and offer technical/scientific support (e.g., remediation initiatives, reports).

  • Partner with Manufacturing to meet production schedules and uphold quality standards. Collaborate with cross-functional teams internally and at external CDMOs on process development and manufacturing-related issues to resolve problems.

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

• Compliance knowledge: proficiency in GMP and regulatory requirements, 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 product development and tech transfer/scale-up activities.

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.

●      Excellent oral and written communication skills.

●      Experience in senior laboratory or operational 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.

●      Proven ability to effectively lead complex projects and participate in teams.

Supervisory Responsibilities:

Ability to manage 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.