Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-UYKMC Cherokee Manufacturing GMP
Recruiter: Erin Wilson
This information is for internals only. Please do not share outside of the organization.
Your Role:
As an ADC Manufacturing Compliance Support Scientist (MCSS), you will primarily provide “off-the-floor” support to the Antibody-Drug Conjugate (ADC) Manufacturing team. In this role, you will focus on reviewing completed batch records, production automation report support; oversight of CAPA/Deviation queue, Logbook compliance, and Operating Procedural compliance as well as occasionally updating operational procedures to ensure smooth, compliant, and efficient manufacturing documentation rotation.
Key Responsibilities:
- 1st shift, Monday – Friday, 7:00 – 3:00pm
- Review batch records, logbooks, and associated documentation to ensure accuracy, completeness, and compliance with quality standards, ensuring adherence to ALCOA+ principles and launching deviation reports as needed.
- Retrieval of production automation reports, to support the completion of the completed batch records.
- Perform oversight and communication to the production team for CAPA completeness compliance, providing notification of pending actions.
- Administer periodic review representation for operating procedures and drive on-time completion of these reviews.
- Support cross-functional communication between manufacturing and quality teams, serving as the primary representative for site huddle meetings, including CAPA, Deviation, and periodic review boards.
- Contribute to continuous improvement initiatives, process optimization, and troubleshooting within ADC manufacturing.
- Ensure safety and compliance with all company policies, cGMP requirements, and ICH guidelines.
Physical Attributes:
- Ability to lift up to 50 lbs.
- Personal protective equipment (e.g., respirators, chemical protective clothing) may be required at times for report/equipment interfacing during manufacturing operations.
Who You Are
Minimum Qualifications:
- Bachelor’s Degree in Chemistry, Biochemistry, Biology or another scientific field
- 3+ years of Industry Production/Laboratory experience in cGMP setting.
- 1+ years of industry Quality Assurance/Validation experience in cGMP setting.
Preferred Qualifications:
- 5 years’ experience in production with 2 years’ experience in quality/validation.
- Capacity to work both independently and collaboratively across departments, with effective cross-departmental communication being critical to success.
- Knowledge of cGMP/ICH Q7 requirements.
- Experience with mono-clonal antibodies, antibody-drug conjugate manufacturing or other highly potent compounds.
- Strong communication and technical writing skills for SOPs and batch record review.
- Proficiency with Microsoft Office applications (Word, Outlook, Excel, etc.).
RSREMD
Pay Range for this position: $ 64,700 - $97,000.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.