• Supervises employees in the Downstream Manufacturing group.
• Fulfill supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include evaluating performance, hiring, training and developing staff; planning, assigning daily tasks; rewarding and disciplining employees; addressing complaints and resolving issues within the group.
• Responsible for maintaining equipment and raw materials inventory.
• Assist in the creation and review of required manufacturing documents (SOPs, MBRs, and Logbooks), protocols to maintain full cGMP compliance.
• Troubleshoot technical problems and recommend solutions for manufacturing equipment and manufacturing documentation.
• Responsible for continuous process improvement.
• Maintain current GMP training for activities in the GMP areas.
• Provide data and other content for drafting and presentation of technical reports.
• Execute quality systems (includes critical work orders, change requests, engineering change, deviations, corrective action preventative action (CAPA).
• Set-up, prepare, and operate manufacturing equipment/ labware/ assemblies (including disposable single-use bioreactors, harvest filtration system, autoclave/sterilizer, analytical instruments (cell count and metabolites), benchtop instruments (pH /conductivity/ osmometer/ SoloVPE, etc.)
• Support Downstream Process Development activities including small scale bioreactors for clone selection, process transfer to GMP production, and clarification of harvest.
• Supervise the chemical weighing and solution preparation for both GMP manufacturing and Process Development functions.
• Provide training, performance evaluation, mentoring, and development of manufacturing staff. Perform technical training (including hands-on and class-based training).
• Execute process development experiments, on as-needed basis, using experimental parameters defined by PD scientists.
• Maintain inspection readiness for GMP facility (General cleaning of GMP work area, bioreactors, equipment, etc.) including waste disposal.

• BS degree in life or physical sciences or >8 years of relevant experience.
• Minimum 5 years of GMP biopharmaceutical manufacturing.
• Proven ability to effectively manage multiple projects with strict timelines.
• Proven decision-making skills.
• Knowledge of chromatography equipment (columns, skids, flow/ UV/ pH/ conductivity/ SoloVPE/ Misc. sensors), filtration equipment, solution preparation equipment (laminar air flow hood, agitator mixers, bench top meters) are essential for this position.
• Diligence and accuracy for record keeping and documentation is mandatory in this position
• Teamwork and communication are key attributes needed for this position, as this role will be part of a small team within downstream purification. A collaborative attitude and a positive work ethic are key traits for success.

PREFERRED SKILLS / COMPETENCIES:

• Knowledgeable in Microsoft applications (Outlook, Word, Excel, PowerPoint, etc.) SAP or Oracle applications.
• Experience in (any or all) technology transfer, validation, filling, and/or facility start-up.
• Hands-on experience with cell culture equipment and related analytical equipment.
• Thorough knowledge of bioprocess validation and associated documentation.
• Management experience and effective communication skills.
• Ability to read, analyze, and interpret general technical procedures.
• Ability to author reports, business correspondence and documentation or procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers and the general public.
• Ability to define problems, collect data, establish facts, and draw solid, valid conclusions.