Sr Quality Control Analytical Scientist

OUR TEAM: We are a growing, collaborative Quality Control team located in a state-of-the-art chemistry manufacturing facility. As a team still in development, we offer the unique opportunity to contribute meaningfully to shaping our systems and culture from the ground up. Our QC laboratory is equipped with advanced instrumentation, including:

• NMR, UPLC, GC, IC, FTIR, LC-MS, ICP-MS, and XRPD
• These technologies support testing of research use only (RUO) products and active pharmaceutical ingredients (APIs)

We work cross-functionally with Validation, Manufacturing, Quality Assurance, Quality Systems, Engineering, and Customs groups. Our efforts focus on transferring analytical methods from our California facility and external customers, supporting both RUO and API pipelines. These transfers include method characterization, familiarization, and validation. In addition, we support manufacturing operations through testing of incoming raw materials, in-process controls, final product release and stability samples. YOUR ROLE: As a Senior Quality Control Analytical Scientist, you will take part in the day-to-day operations of the QC lab while continuing to grow your technical and leadership skills. This role offers exposure to a broad range of analytical technologies and quality systems in both regulated and research use environments. You will be trained across diverse analytical platforms and QC areas, support and lead method transfer and validation, collaborate on cross-functional projects and, as applicable, mentor junior staff and guide best practices. This role involves a good balance of daily operations and independent project leadership. You will contribute meaningfully while continuing to develop as a technical leader. YOUR EXPERIENCE: You are collaborative and proactive in a dynamic, cross-disciplinary environment. You are skilled in several analytical techniques with a willingness to learn and grow. You have experience in cGMP environments, with working knowledge of ICH and FDA guidelines. You are adaptable and able to work effectively across both regulated (API) and non-regulated (RUO) contexts.

JOB OBJECTIVE: Characterize, validate, and perform analytical methods for current and new products for a company that manufactures small molecules used in life science research, medical devices, and pharmaceuticals.

CORE DUTIES:

1. Perform analytical method characterization and validation when required to support process improvement, product transfer, or new product realization projects.

2. Develop reports, protocols, and Standard Operating Procedures for new and current analytical methods and instrumentation.

3. Mentor & train Junior scientists and aid when needed in high throughput times of intermediate, final product, and raw material testing.

4. Maintain a working knowledge of QC Lab instrumentation and associated analytical methods. Perform analytical method evaluation and/or re-validation upon request.

5. Evaluate and interpret analytical testing results. Act as primary reviewer of analytical data generated from raw materials test, In process testing, intermediate and final product testing.

6. Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations nonconformances as required.

7. Develop and maintain a product/intermediate/reference standard stability, retention, and retest program.

8. Prepare and/or maintain QC testing materials, retention samples, and reference standards.

9. Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA’s as needed.

10. Write, review and revise, as necessary, Inspection Plans, test methods, SOPs, and other QC Lab procedures, for accurate and complete content, and ensuring they meet documentation policy and requirements.

11. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

12. Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.

13. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Degree in Chemistry or related lab science. MS with 2-4 years, or BS with 4-7 years direct experience in a Quality Control lab using advanced equipment and techniques. Extensive experience in method validation.

2. The ideal candidate will have extensive knowledge of the use and troubleshooting of typical analytical instruments. These include GC, ICP-MS, LC-MS, HPLC, NMR, XRPD, FTIR, Extinction Coefficients, Karl Fisher, fluorometer and luminometer.

3. Candidate will have a working knowledge of and the ability to determine solubility, viscosity, mass, and conductivity.

4. Knowledge with basic descriptive statistics such as mean, standard deviation, confidence intervals, and linear regression. Experience with use of statistical tools to analyze data.

5. The ideal candidate will have a proven track record in new method characterization and method validation.

PREFERRED QUALIFICATIONS:

1. MS with 5-7 years’ experience in method development and validation using several of the following: GC, ICP-MS, LC-MS, HPLC, NMR, XRPD, FTIR, Extinction Coefficients, Karl Fisher, fluorometer and luminometer.

2. Experience with ISO 9001, cGMP, 21 CFR 211, and ICH Q7 requirements.

3. Ability to work independently and as part of a team with proven results in problem identification, planning, and communication.

4. Desire for future growth into QC lab as a leader.

5. Organizational and multi-tasking skills; able to manage several tasks simultaneously.

PHYSICAL DEMANDS:

1. This position will require analyst to perform some QC testing outside of normal business work hours in order to support manufacturing.

2. Must be able to stand for long periods.

3. Must be able to identify and distinguish colors.

4. Ability to work with chemical reagents required for analytical testing.

5. Must be able to wear appropriate personal protective equipment such as lab coat, mask, gloves, and safety glasses.

6. Ability to move objects averaging ten pounds.

7. Must be able to use a computer for extended periods of time throughout the day.

8. Ability to travel.

At Promega, we are committed to building a diverse workforce that reflects the communities we serve and creating a culture where everyone belongs. As an Equal Opportunity Employer, we welcome and encourage applications from all backgrounds, ensuring that employment decisions are made fairly and equitably.