JOB DETAILS
Associate Director, Manufacturing, Downstream
CompanyBora Biologics
LocationSan Diego
Work ModeOn Site
PostedDecember 21, 2025
About The Company
Bora Biologics: Accelerating Success in Biologics Development
With a proven track record of over 100 successful cGMP manufacturing batches and the development of more than 42 biologics and biosimilars, Bora Biologics exemplifies how experience drives success. We offer agile, comprehensive end-to-end CDMO solutions that optimize time and cost efficiencies for biopharma companies around the world.
Leveraging our global CDMO capabilities, our state-of-the-art, FDA-registered facility in the U.S., and our deep expertise in biologics development and manufacturing, we provide efficient and effective pathways to market for clients.
We specialize in a diverse range of biologics, including monoclonal antibodies (mAbs), bi-specifics, fusion proteins, recombinant proteins, and enzymes. From cell line development to commercial manufacturing, our team brings extensive global and regional regulatory affairs expertise to ensure compliance and success at every stage of the process.
+ Mammalian and Microbial GMP Manufacturing
+ Early, Late-Stage and Commercial Production
+ Integrated Process and Analytical Development
+ Formulation and Drug Product Development
+ Quality Control and Assurance
State-of-the-Art Facilities & Highlights
---------------
Bora Biologics | San Diego, California, USA
+FDA Registered
+130,000 sf GMP and R&D space
+14,000 sf temperature controlled GMP warehouse
+Single-Use Bioreactors (SUBs): 2 x 50L, 2 x 250L, 4 x 1000L , 2 x 2000L (in plan)
+Stainless Steel Fermentors: 1 x 150L, 1 x 300L (SUF)
+3 GMP suites
Bora Biologics | Zhubei City, Taiwan
+70+ cGMP batches with 100% success rate continuously since 2014
+48,000 sf of GMP and R&D space
+cGMP, ICH, FDA, EMA, TFDA, PIC/S
+Single-Use Bioreactors (SUBs): 2 x 50L, 4 x 500L (2 in plan)
Partner with us today to discover how our EXPERIENCE can accelerate your success.
About the Role
Description
SUMMARY
The Associate Director, Manufacturing – Downstream (Purification), is responsible for providing technical and tactical leadership to the downstream manufacturing organization, with a focus on purification processes for microbial and mammalian cell culture–derived drug substances. This role provides strategic and operational guidance to downstream manufacturing teams, supporting the implementation and expansion of downstream manufacturing projects and capabilities at Bora Biologics.
- JOB RESPONSIBILITIES
Essential
- Lead and oversee downstream operations (harvest, column chromatography, column packing, TFF, VF, Bulk Fill) for clinical and commercial manufacturing of drug substances derived from microbial and mammalian expression systems.
- Manage and develop the downstream manufacturing team, including recruiting, hiring, motivating, training, performance management, and career development.
- Partner cross-functionally with Process Development, Manufacturing Science & Technology, Quality, Quality Control, Supply Chain, Drug Product Manufacturing, and Facilities & Engineering to drive operational excellence and alignment.
- Accountable for meeting downstream manufacturing goals for yield, purity, and process success rates.
- Oversee purification campaign scheduling, ensuring on-time and in-full delivery of production commitments.
- Ensure that all documentation, including batch records, procedures, and validation reports, is accurate, compliant, and maintained per GMP, environmental, and safety standards.
- Represent downstream manufacturing during audits, regulatory inspections, and internal cross-functional meetings.
- Support the development, recommendation, and execution of near- and long-term strategies to improve downstream manufacturing efficiency, cost, and robustness.
Supplemental Responsibilities
- Assist with preparing budgets, forecasts, and key business performance indicators for downstream operations.
- Other duties/projects that may be assigned.
Requirements
Education
- BS, or advanced degree in chemical engineering, biochemical engineering, biochemistry, or a related scientific discipline with 10 years of experience in the pharmaceutical/biotech industry, or equivalent education/or experience.
- Minimum 5 years of management experience
Knowledge, skills, and abilities
- Industry experience in GMP downstream bio/pharmaceutical drug substance manufacturing.
- Experience with regulatory agencies, including inspections and responses.
- Direct experience with long-range programs and project planning for a biopharmaceutical company.
- Advanced communicator of ideas, project goals, and results.
- Six Sigma or Lean Manufacturing experience is preferred.
- Exceptional at leading teams, motivating staff performance, and building collaboration.
- Exceptional verbal and written communication skills.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, etc.).
Key Skills
Downstream OperationsTeam ManagementCross-Functional CollaborationGMP ComplianceRegulatory ExperienceProject PlanningSix SigmaLean ManufacturingCommunication SkillsPerformance ManagementPurification ProcessesBudget PreparationOperational ExcellenceTechnical LeadershipTraining and DevelopmentProcess Improvement
Categories
HealthcareManagement & LeadershipManufacturingScience & ResearchEngineering
Job Information
📋Core Responsibilities
The Associate Director will lead and oversee downstream operations for the manufacturing of drug substances, ensuring compliance and efficiency. They will also manage the downstream manufacturing team and collaborate with various departments to achieve operational goals.
📋Job Type
full time
📊Experience Level
10+
💼Company Size
58
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
Apply Now →
You'll be redirected to
the company's application page