Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
The Manager, Quality Control Chemistry will develop, implement, and maintain the activities of quality control systems related to chemistry testing.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Job Description
Scope of Authority
- span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Quality Control Chemistry Department
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
QC Chemistry Operations
- Ensure cGMP compliance across the quality control chemistry function.
- Oversee the product testing program including product stability testing, raw material testing, product release testing, and product in-process testing.
- Implementation and maintenance of quality control systems related to chemistry.
- Scheduling assays, personnel and equipment to ensure timely completion of projects.
- Represent QC at inter-departmental meetings to support projects, validations, production efforts, and testing scheduling.
40%
Investigations
- Oversee and manage OOS, investigations and corrective action system to assure compliance and timely and accurate completion of reported events.
15%
Documentation and Data Reporting
- Documents and reviews test results to meet regulatory requirements and expectations.
- Review of data generated in the laboratory prior to release of information.
- Ensures timely and appropriate communication of results.
- Direct data trending and summarization.
- Generation of Standard Operating Procedures and protocols developed for routine testing, special studies and validation efforts.
10%
Laboratory Management
- Adheres to Company safety procedures and guidelines on a daily basis.
- Development of staff to improve individual and departmental performance.
- Trains members of department and other departments as necessary.
- Balancing of priorities and resolution of conflicts within groups.
- Troubleshoots problems that arise which affect the routine operations within the QC functional group.
- Communication of policies and procedures to QC staff.
15%
Technical Oversight
- Oversees validation of test methods to support release of materials for production or products for commercial or clinical use.
- Optimizes test procedures to improve efficiency whenever possible.
- Reviews, designs and implements methods to increase compliance, efficiency, and productivity of operations.
- Reviews validation protocols and reports as necessary.
10%
Troubleshooting
- Assists in validation of new equipment. Recognizes, troubleshoots, and resolve problems with equipment or assays.
5%
Other Tasks
- Other Duties as assigned by QC management.
5%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Bachelors of Science in Chemistry, Microbiology, or other relevant field required (M.S. a plus).
- Scientific Field Typical Experience: 10+ years of experience.
- Previous Biologics, biotech or biopharmaceutical experience required.
- Demonstrated quality experience as it relates to quality control systems which integrate FDA/ICH/EU GMPs.
- Previous management or supervisory experience required.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Strong knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA) preferred.
- Working knowledge of cGMP practices, ICH requirements, stability, and validation.
- Understanding of basic statistical analysis and familiarity with the use of databases is desirable.
Skills
&
Abilities
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Strong verbal and communication skills with ability to interact with all levels throughout organization.
- In addition, demonstrated excellent interpersonal skills and flexibility, including demonstrated ability for successful leadership, influence and negotiation.
- Ability to coordinate multiple priorities in a fast-paced environment.
- Solid organizational, analytical and problem solving skills
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Will have to lift containers weighing approximately 40 pounds.
- Business travel up to 10 % of the time.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
