Manufacturing Manager- Upstream

  • Location: College Station, TX
  • Type: Direct Hire
  • Job #34310


The Manufacturing Manager, Upstream is responsible for assisting in the planning, directing, and coordinating of the activities related to the Upstream manufacturing processes while maintaining a highly effective operation leading to the production of safe, efficacious and compliant therapeutics.  The Manufacturing Manager, Upstream will oversee the cGMP production and upstream manufacturing systems working directly with cell culture and viral propagation techniques, cell culture and bioreactor operations, bacterial and fermentation operations, pDNA, protein, and yeast related operations, and aseptic techniques while following cGMP procedures.

Essential Functions:

  • Oversee and provide leadership to the Upstream manufacturing operations.
  • Assist in organizing, managing and improving Upstream manufacturing operations activities in support of the development of new products or processes and the manufacture of clinical products according to cGMPs in a timely manner.
  • Ensure full compliance to OSHA and cGMP regulations of the Upstream manufacturing operations at all times and working in concert with the Manufacturing Director, QA, Engineering and Materials Management to ensure that the Upstream manufacturing process is performing as required to meet client commitments.
  • Working with the Manufacturing Director , Metrology, Engineering and Facilities groups on site ensuring compliance and effectiveness through maintaining appropriate Engineering standards, maintenance and calibration of equipment according to all required standards.
  • Assist in directing the Upstream manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for multiple products using single use cell culture vessels/bioreactors.
  • Assist in maintaining the Upstream processes at the highest level of cGMP compliance per FDA and customer expectations.
  • Help build, maintain and motivate the Upstream team in order to achieve productivity targets and output requirements to service clients with products on time.
  • Assist the Manufacturing Director – and the Executive Leadership Team in establishing strategic directions for Upstream manufacturing resources and activities, and setting objectives to maximize the value of the organization.
  • Ensure continued operational efficiencies for Upstream manufacturing are realized with reliable schedule adherence, lower conversion cost and increased productivity.
  • Help establish priorities and assure adequate Upstream resources to complete projects in a timely manner.
  • Assist in completing investigations in a timely manner and ensuring root causes are correctly identified.
  • Work directly with Manufacturing Director, Validation, Quality Assurance, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in Upstream manufacturing operations.
  • Monitor and report progress of the Upstream processes to ensure meets the client and Company objectives.
  • Participate in and represent Upstream manufacturing operations in pre-approval inspections, FDA audits and client audits.
  • Report Upstream manufacturing and quality performance to the Manufacturing Director on a regular (i.e., monthly) basis through the use of various site metrics.
  • Ensure adequate levels of materials are maintained in support of the Upstream manufacturing processes while adhering to corporate inventory objectives.
  • Assist in developing Upstream manufacturing plans and procedures for maintaining high standards of Upstream manufacturing operations to ensure that products conform to established customer and company quality standards.
  • Formulate and recommend Upstream manufacturing policies and programs that guide the organization in maintaining and improving its competitive positions and the profitability of the operations.
  • Direct and monitor team members to accomplish goals of the Upstream manufacturing plan, consistent with established manufacturing and safety procedures.
  • Hire, train, develop and evaluate Upstream manufacturing staff. Take corrective action as necessary on a timely basis and in accordance with Company policy.  Ensure compliance with current federal, state, and local regulations in consultation with the Manufacturing Director and Human Resources as appropriate.
  • Perform other duties and projects as assigned and required.

Required Skills & Abilities:

  • Single use
  • monocal antibodies (mabs)
  • Strong leadership qualities and demonstrated success in management of change.
  • Ability to coordinate, facilitate and organize resources.
  • Ability to develop strategic relationships; strong verbal and written communication skills; good presentation skills.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to work effectively under extreme pressure to meet deadlines.
  • Well organized with ability to handle multiple activities simultaneously.
  • Detail oriented and accurate.
  • Excellent computer skills and proficient in MS Office (Word, Excel, Outlook, PowerPoint).
  • Good interpersonal skills with an understanding of diverse backgrounds and an emphasis on communication: training, team building, negotiation skills, interdepartmental interactions, leadership and supervision (motivation, directing) and management (planning, budgeting, etc.)
  • Ability to hire, train, and develop employees to grow within the organization.

Supervisory Responsibilities:

  • The following positions will directly report to the Production Manager, Upstream – : supporting technical staff.

Minimum Qualifications:

  • Master's degree preferably in Science, Engineering, or other related field and four (4) years of relevant related experience including four (4) years of supervisory/management experience; OR
  • Bachelor’s degree preferably in Science, Engineering, or other related field and sic (6) years of relevant related experience including four (4) years of supervisory/management experience; OR
  • Associate degree preferably in Science, Engineering, or other related field and eight (8) years of relevant related experience including four (4) years of supervisory/management experience; OR
  • High school / GED in a related field and ten (10) years of relevant related experience including four (4) years of supervisory/management experience
  • Above experience must include four (4) years’ GMP experience
  • Experience with cultivation at a minimum of pilot scale cell culture vessels.
  • Experience with Mammalian Cell, Insect Cell, Yeast and Bacterial Cell Lines
  • Experienced with MAb, pDNA, and Viral Propagation technologies.
  • Single use technology experience. 

Preferred Qualifications:

  • Experience in logistics/planning
  • Lean Six Sigma – Black Belt


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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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