Sr. Supervisor Raw Materials Laboratory VIII
St. Louis, MO, USA
Job Description
Posted Tuesday, January 16, 2024 at 5:00 AM
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Ready to work with purpose? Look no further, we are hiring for a talented and passionate Sr. Supervisor Raw Materials Laboratory to join our Production team.
ROLE SUMMARY
This position provides direct supervision to colleagues testing pharmaceutical raw materials, active product ingredients (API), and water samples in the Quality Control (QC) Laboratories. This individual will be responsible for these colleagues in meeting cGMP, Data Integrity requirements, and applicable company or compendial standards. Key responsibilities include the testing of in-process, finished product, and stability samples following KindevaDD and compendial test procedures. Compliance with laboratory procedures pertaining to laboratory investigations and assures the cGMP condition of the laboratory and staff with regards to Training, Education, and Documentation practices. In addition, this position is responsible for ensuring proper Qualification and Maintenance of laboratory equipment and that the department is proficient in the generation of concise and clearly written reports/SOPs. Ensures compliance with all Meridian Medical Safety (EHS) initiatives and programs.
ROLE RESPONSIBILITIES
- Ensures that laboratory practices comply with current compendia, SOPs, cGMP, Data Integrity, and regulatory requirements.
- Conducts timely Laboratory Investigations as required following appropriate procedures.
- Schedules and manages laboratory assignments. Coordinates with Manufacturing to ensure adequate analytical support is provided regarding sample testing and result reporting.
- Provides and ensures proper training of laboratory colleagues. Evaluates the training needs of QC personnel; develops programs to address training needs along with the site training department.
- Audits tests, assays, specifications, and other laboratory functions used to monitor products. Recommends or implements changes where necessary to ensure reliability, accuracy, and adequacy of specifications and methods that monitor product quality.
- Drafts and reviews laboratory procedures including, but not limited to SOPs, test methods, and other required documentation.
- Oversees the site chemical hygiene plan (CHP) as per OSHA standards. Maintains a safety standard for the QC laboratory.
- Provides necessary technical and administrative support to laboratory colleagues.
- Provides technical support to other departments.
- Evaluates and recommends new equipment and technology associated with raw material related testing.
- Leads the installation, qualification, operational and performance qualification of analytical instrumentation in accordance with corporate and cGMP guidelines.
- Provides activity/efficiency and trend reports to senior management; attends meetings with other departments; provides laboratory services to other departments and external customers as needed.
- Coordinates personnel activities such as vacation, sick time, timecards, etc. to ensure appropriate coverage in the QC laboratory at all times; addresses personnel issues with the assistance of HR as they arise; assists in training new personnel; counsels and disciplines personnel as needed; conducts performance appraisals for direct reports; composes performance improvement plans for personnel with performance issues and reviews with HR.
- Establishes metrics to monitor performance and efficiency, including compliance metrics (such as LIR, CAPA, Commitments, Training).
- Evaluates any Regulatory or Compendial Notifications for potential impact to the site.
- Reviews and supports SOP change control requests, method validation/verification protocols, and reports related to such changes.
- Performs other related duties as assigned.
QUALIFICATIONS
Education: This position requires a Bachelor's degree in Chemistry.
Experience Technical Skill Requirements: 3 or more years’ experience and/or training; or equivalent combination of education and experience in the pharmaceutical industry. To perform this job function, the individual must have knowledge and experience in compendia (USP, EP, BP), spectrophotometric instrumentation (UV, FTIR), polarimetry, auto titrators, chromatography (HPLC, UPLC, IC, and GC), and wet chemistry techniques. Experience with instrumentation, troubleshooting, data analysis, and maintenance is also required. This position requires technical writing skills to clearly and concisely read and write reports, document investigations, and related SOPs. Ability to read, analyze, and interpret technical procedures and government regulations. Ability to understand and apply laboratory tasks and data, mathematical concepts as related to statistics, including the ability to apply mathematical operations to such tasks to ensure accurate reporting of laboratory results. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions, interpret results, and describe/communicate information to leadership.
Computer Skills: The individual should have a working knowledge of Microsoft Office (Word, Excel, Access, and PowerPoint), Microsoft Project, and applicable laboratory instrument/equipment software in support of data integrity and operational compliance. Previous experience with Empower Chromatography Data System and LIMS application are desirable.
Unusual attendance and/or weekend work or travel may be required to support laboratory activities.
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state, or local law.
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