Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
Management and oversight of the QC Microbiology labs ensuring that staff are trained and resourced to execute their duties in a reliable and compliant manner, in support of in-process testing, raw material or product release, stability testing, or environmental monitoring.
In addition, this role ensures testing is performed to support product development/product discovery, and characterization/comparability of products and impurities to support process/product/formulation development, licensure, and product investigations.
ESSENTIAL FUNCTIONS
- Responsible for microbiological testing of raw materials or in-process and finished drug product in conformance with specifications, and for investigations in response to out of specification or out of trend results.
- Responsible for microbiological testing to support validations, stability or nonclinical/ clinical studies (GMP or GLP compliant), product development/product discovery, and characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
- Responsible for design and testing of batch specific and facility environmental monitoring programs to meet compendial requirements.
- Serves as a technical subject matter expert on microbiological assays and techniques.
- Responsible for leading the Quality Control Microbiology team through hiring, performance review, and ongoing training and development. Develop and coach direct reports to achieve goals based on corporate objectives and results by optimizing resources and building team effectiveness. Regularly communicate corporate mission/values, portray the values, recognize staff exhibiting the values and hold people accountable if values aren’t exhibited.
- Direct the work activities for unit staff to ensure that corporate, project and unit objectives are completed efficiently within defined timelines.
- Develops a lifecycle and systems-based approach to design and implementation of processes and procedural improvements.
- Implement plans and procedures such that work areas meet all company policies and standards for hygiene, safety and security and lab activities are conducted according to safety guidelines, policies and legislation.
- Review and approve unit procedures relating to testing, sampling, or related operations.
- Provide data and support including technical writing for regulatory submissions.
- Manage annual operating and capital budgets for the department, including approval of purchase requisitions and implementation of capital purchases.
- Ensure that laboratories and procedures are in compliance with GLP/GMP requirements, participate in internal and external/regulatory audits, and manage corrective actions/responses.
GxP Duties
- Ensures compliance with the requirements of current Good Manufacturing Practices (cGMP).
- Ensures adequate resources including personnel, equipment, facilities, and materials are provided.
- Ensures the initial and continuing training of personnel.
- Establishes, implements, and maintains departmental procedures consistent with company policies and standards for hygiene, safety, and security to assure compliance with applicable regulations, guidance documents, and industry best practice.
- Identifies, investigates, and reports to management issues which may affect product Safety,
- Quality, Identity, Purity, or Potency (SQIPP).
- Ensures that appropriate validations are completed.
- Approves, selects, and monitors contractors/analysts.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Holds a university degree in microbiology or related field of study.
- Minimum 6 years directly related experience in a similar position, preferably in the pharmaceutical sector.
- Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
- Proficient and professional communicator, verbally and in writing.
- Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
- Strong organizational and interpersonal skills and the ability to work collaboratively with others.
- Proficient in complex procedures and problem solving.
- Proven ability to manage with leadership and independence with a focus on excellence, innovation, and teamwork.
- Comprehensive knowledge of pharmaceutical GLPs and GMPs
- Comprehensive knowledge of regulatory/industry guidance
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