Manage operation of assigned manufacturing area to meet client and regulatory requirements.
Essential Duties and Responsibilities:
- Oversee day to day operations in assigned area of Contract Manufacturing Facility.
- Ensure that equipment and instruments are properly qualified and maintained.
- Ensure that staff is properly trained.
- Write and/or approve manufacturing documentation, including validation protocols, SOPs, and master batch records.
- Review completed documentation to ensure GMP compliance.
- Plan and order materials for manufacturing campaigns.
- Review client processes for compatibility with plant capabilities and GMP requirements.
- Work with client representatives, Process Development, and technical support to transfer manufacturing processes.
- Coordinate with other departments to schedule work in processing and support areas or work that affects processing and support areas.
- Identify and maintain relationships with quality vendors of supplies, instruments, and equipment.
- Identify processing technologies and capabilities to add to Cytovance’s portfolio.
- Work with QA to investigate and resolve nonconformances.
- Other duties as assigned.
- Directly supervises 6 - 9 employees in the Upstream Microbial Department.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Bachelor’s degree in scientific discipline
- 5-10 years of experience in Microbial CMO environment.
- GMP manufacturing experience, preferably in a multiproduct facility
- Experience as manager or supervisor.
- Experience with relevant biotech processing equipment: Cell Culture, Bioreactors, Recovery
- Experience with disposable processing equipment preferred
- Experience starting up a new facility strongly preferred
- Ability to operate equipment as well as supervise others.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals; and risk of electrical shock. The noise level in the work environment is usually moderate. A large amount of the work is completed in a cleanroom environment. While working in the area the gowning requirements are safety glasses, shoe covers, hood, gown, mask boots and gloves. Working conditions can include standing for long periods of time