|Date Posted||January 3, 2021|
|Address||2800 Woods Hollow Rd|
JOB OBJECTIVE: Leading a team of scientists for the launch of a brand new chemical manufacturing facility, including recruiting an energetic and talented team, qualification and commissioning of new equipment with automation, as well as technology transfer and scale-up. This is an excellent career development opportunity to be a part of the exciting and challenging project of preparing the plant for production as well as producing our first batches of components to support Promega products.
1. Supervises, trains, and motivates the manufacturing team in production to meet timelines.
2. Conduct performance, career development, and salary reviews. Review training needs to provide training opportunities for staff to develop personal and job-related skills.
3. Reviews and approves documentation to ensure accuracy, clarity, and appropriate technical and quality system content.
4. Ensures that all employees follow safety guidelines, PPE requirements, and behavioral safety expectations.
5. Assists in manufacture of a wide variety of chemical compounds, as necessary.
6. Functions as lead production scientist for a program, as necessary.
7. Documents all production activities in accordance with Good Documentation Practices (GDP).
8. Effectively collaborates across departments to ensure production timelines are met.
9. Safely handles, transfers, and manipulates chemicals in accordance with all policies and procedures while utilizing appropriate Personal Protective Equipment (PPE) and engineering controls.
10. Assists with recruitment activities.
11. Prioritizes production activities to promote efficiency while adapting to production constraints.
12. Reacts to complex challenges with appropriate solutions, ensuring appropriate notification to all affected parties.
13. Assists process transfer scientists and engineers during project design and transfer.
14. Drafts batch records and standard operating procedures.
15. Participant and Incident Commander for Spill Response Team.
16. Understands and complies with ethical, legal, and regulatory requirements applicable to our business.
1. Orders equipment, commodities, and other materials as required.
2. Identifies and implements complex process improvements to safety, quality, and productivity by leading an interdepartmental team of SMEs.
3. Additional responsibilities as assigned by manager and/or director.
4. Spill and incident response.
1. B.S. / M.S. / Ph. D in chemistry, biochemistry, or related scientific discipline and 7+ years of related experience in a GDP or GMP chemical manufacturing environment.
2. Demonstrated leadership aptitude.
3. Experience handling hazardous compounds and wearing PPE.
4. Glassware, Kilo, and Pilot Plant Scale manufacturing experience, up to 500gal reactor size.
5. Excellent written and verbal communication skills.
6. Thrives in a team environment.
7. Familiarity with chemical processes such as distillation, flash chromatography, filtration, and reactions.
8. Demonstrated proficiency in analytical data interpretation (HPLC, GC, NMR, etc.).
9. Mechanical aptitude and troubleshooting skills.
10. Experience in process transfer or scale-up involving complex chemistry.
1. Experienced in Process Development and Transfer from bench-scale to production-scale.
2. Nuanced understanding of quality systems affecting processes and ability to navigate a challenging regulatory environment.
1. Ability to stand for long periods of time.
2. Ability to use respiratory protection including respirators and supplied air.
3. Ability to maintain focus for extended periods of time while monitoring critical equipment.
4. Ability to utilize a pallet jack, drum dolly, hoists, and other support equipment to move heavy materials.
5. Ability to lift 50lb using safe lifting techniques.