Senior Process Engineer, Technical Operations - Small Molecule Drug Substance

We have an exciting opportunity for a Senior Process Engineer, Technical Operations – Drug Substance to join our growing team. At our company, we aspire to be the premier research‑intensive biopharmaceutical company, using the power of leading‑edge science to save and improve lives worldwide. The role is based at a purpose‑built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the United States.

Key Responsibilities

• Technical & Process Leadership
  • Provide technical leadership for API manufacturing processes, including chemical synthesis, purification and isolation, crystallization and drying operations.
  • Act as process owner / SME for assigned unit operations, equipment, or product processes.
  • Lead technical input to the Capital Project Team, supporting design reviews, commissioning, qualification, and startup readiness.
  • Lead or coordinate process scale‑up, technology transfer, and validation activities (e.g., pre‑PPQ, PPQ).
  • Analyze and interpret process data to drive data‑driven decision‑making and performance improvements.
  • Provide advanced troubleshooting support during manufacturing campaigns, resolving complex technical issues.
• Technology Transfer & Commercialization
  • Lead or play a key role in executing technology transfers for new products and processes into the facility.
  • Partner with global R&D and network sites to ensure robust process knowledge transfer and right‑first‑time startup.
  • Drive process fit assessments, scale‑up strategy, and manufacturability evaluations.
  • Own or guide development and optimization of batch documentation and process instructions.
  • Support integration and industrialization of new technologies into manufacturing operations.
• Process Optimization & Operational Excellence
  • Partner with Manufacturing to ensure safe, efficient, and reliable plant performance.
  • Identify, prioritize, and implement improvements in process robustness, product quality, yield and throughput.
  • Lead or drive continuous improvement initiatives aligned with operational excellence objectives.
  • Use structured problem‑solving approaches (e.g., RCA) to resolve deviations and recurring issues.
  • Monitor process performance, trends, and cycle times to proactively identify risks and opportunities.
  • Contribute to debottlenecking, cleaning, and turnaround optimization strategies.
• Compliance & Documentation
  • Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards.
  • Provide technical leadership in campaign preparation, execution, and post‑campaign review.
  • Own or approve key batch record updates and process documentation improvements.
  • Support regulatory inspections and audits, providing technical input and ensuring inspection readiness.
  • Ensure high standards of data integrity and technical documentation quality.
• Cross‑functional Collaboration & Influence
  • Act as a technical representative within cross‑functional teams including Manufacturing, Quality, Engineering, Supply Chain, and R&D.
  • Provide clear technical direction and influence decision‑making across projects and operations.
  • Lead or contribute to cross‑functional initiatives, driving alignment and delivery of key milestones.
  • Support knowledge sharing and best‑practice transfer across the network.

Qualifications

• Degree in Chemical Engineering, Chemistry, or related discipline.
• Typically 5+ years’ experience in API manufacturing, process development, or pharmaceutical operations (PhD may offset experience).
• Strong experience in API processing operations and scale‑up to commercial manufacturing.
• Demonstrated involvement in technology transfer, validation, and process support.
• Good understanding of cGMP manufacturing and regulatory expectations.
• Experience in troubleshooting and process optimization in a manufacturing environment.

Key Skills

• Strong analytical capability with ability to interpret complex data and drive decisions.
• Demonstrated ability to lead technical workstreams or projects.
• Excellent problem‑solving skills with structured, science‑based approach.
• Effective communicator with ability to influence cross‑functional stakeholders.
• Proven ability to manage multiple priorities and deliver results in a dynamic environment.
• Proactive, self‑driven mindset with strong focus on continuous improvement and ownership.

Benefits

• Competitive salary range: $117,000.00 – $184,200.00.
• Eligible for annual bonus and long‑term incentive, if applicable.
• Comprehensive benefits package including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

Location and Working Conditions

• United States and Puerto Rico residents only.
• Location: San Francisco, California – preferred for candidates meeting the San Francisco Fair Chance Ordinance.
• Location: Los Angeles, California – inclusive of all qualified applicants regardless of criminal histories.
• Domestic relocation support available. No visa sponsorship.
• Travel required: approximately 10%.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC websites.