As part of the Analytical Production Securitization Industrialization team in the Engineering and Industrialization department, the Associate Process Scientist, Biochemist will perform projects to support the manufacturing of BACT/ALERT® Culture Media products. Within this role the Associate Process Scientist will be required to interface with Manufacturing, Quality Control, Quality Assurance / Validation, R&D, Purchasing, Supply Chain, and other functions as required in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands.
- In this position the Associate Process Scientist’s primary focus will include the analysis of both biological and chemical derived raw materials for secondary/alternate sourcing projects in order to achieve site securitization and/or cost saving initiatives.
- Analysis includes laboratory testing at the bench scale, performance testing on final product, and large scale validation activities.
- Strong knowledge of cGLP and cGMP, microbial testing (environmental monitoring, bioburden, isolating and monitoring microorganism cultures) and analytical instrumentation proficiencies (HPLC, GC, SEC, pH, FTIR) will be required, along with understanding impact to both upstream and downstream processes when considering raw material changes.
- Management of multiple projects will be required, whereby assessments are generated to evaluate interim progress and effectiveness.
- Project leadership is necessary in order to guide timelines, adjust expectations, and collaborate cross-functionally.
- This position will require a strong knowledge of both chemistry and microbiology in order to provide subject matter expertise in evaluating raw material and process changes in both planned and unplanned circumstances, provide departmental representation on cross-functional teams, as well as, participate and identify improvement opportunities and strategies.
- Perform all work in compliance with company quality procedures and standards.
- Develop Job Aids to support routine activities.
- Collaborate with cross-functional teams, including Manufacturing, to build product on the Production lines with the intention of product and release testing.
- Author and revise Industrialization Studies and Technical Assessments.
- Manage Change Controls and author/revise material release documentation.
- Champion failure root cause analysis.
- Demonstrating the behaviors of being a self-starter who is organized, detailed, conscientious, and ambitious. Lead by example.
- Models behaviors such as being a team player with a positive attitude, approaching projects/tasks with a sense of ownership, and developing and improving the skill level and behaviors of others.
- Performs documentation requirements in a cGMP compliant manner in accordance with Quality Policies.
- Responsible to follow all site Safety Policies/OSHA policies including requirements as related to personal protection equipment as needed to perform routine and non-routine duties.
- Takes an active / leading role in continuous improvement as well as infrastructure improvement toward the implementation of sustainable reliability based maintenance program.
- Ability to work effectively as part of a team in addition to autonomously as required.
- Effectively communicates within team and interfaces with other site departments, verbally and written.
- Ability to maintain and execute a Project Schedule.
Studies and Experience:
- B.S. in Biochemistry or closely related field, with minimum 3 years of experience required
- M.S. in Biochemistry or closely related field, with minimum 1 year of experience preferred.
- FDA regulated cGMP industry experience preferred.
- Minimum 1 year of Project Management experience preferred.
- Minimum 1 year of experience working in a cGMP environment preferred.
Skills and Qualifications:
- Robust technical background in analytical chemistry methods, microbiological methods, and aseptic technique.
- Basic SAP knowledge, or a related ERP system.
- Computational aptitude for scaling formulation recipes.
- Experience with data analysis and statistical software competence, Minitab preferred.
- Experience with implementing changes/qualifications through change control process.
- Strong project management skills, familiarity with Microsoft Project.
- Direct experience in authoring and review/approval of documentation.
- Agility to re-prioritize workload independently due to business needs.
- Exhibit instrument and method trouble shooting skills (HPLC, GC, SEC, pH, FTIR, BCID, etc).
- Self-directed individual who can work with limited direction.
- Excellent organizational, analytical, and communication skills.
- Demonstrated ability to work in a team environment.
Ability to remain in stationary position, often standing, for prolonged periods.
Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day.
Ability to work in a lab executing activities including working in biosafety cabinets for prolonged periods.