Associate Director, Manufacturing, Downstream

Bora Biologics•San Diego, CA

10d

About The Position

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

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
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.
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.).

Nice To Haves

Six Sigma or Lean Manufacturing experience is preferred.

Responsibilities

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.
Assist with preparing budgets, forecasts, and key business performance indicators for downstream operations.
Other duties/projects that may be assigned.