Manager CRS Laboratory

Johnson & Johnson Innovative Medicine•Malvern, PA

2d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Control Job Category: People Leader All Job Posting Locations: Malvern, Pennsylvania, United States of America Job Description: POSITION SUMMARY: Manages all aspects of Quality Control (QC) in the Clinical, Release, and Stability (CRS) Laboratory, in support of designated Janssen Supply Chain (JSC) sites, and in full compliance with established cGMP and JSC requirements. Develops and implements long-term strategy, and execution of Quality Control programs. Ensures department staff complies with all J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines, including FDA, EMEA and regulatory bodies of any applicable non-EU countries, NATURE OF TASKS: Manages team of people leaders and technical professionals within the QC department. Assigns work, provides overall direction, coaches and mentors, develops capabilities and takes necessary disciplinary actions. Responsible for overseeing and managing processes for; Ensuring adequate training (skills-based, cGMP and safety) of management and associates within the department. Raw material, in-process, environmental/utility, product release, and stability testing. Investigation of laboratory non-conformances (events, deviations, and invalid assays). Maintenance, calibration and qualification of laboratory instruments and equipment. Test method verification, qualification, validation and/or transfer activities in the QC laboratories. Process Performance Qualification and Continued Process Verification activities associated with QC laboratory testing. Material evaluation/testing as part of the Supplier Material Qualification (SMQ) process. Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations. Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements. Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs. Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures. Manages departmental budget and resources; prepares staffing plans. Makes adjustments to roles and responsibilities of department to meet business needs. Reviews and/or approves quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance investigations, CAPA, and change controls associated with the QC laboratories. Supports internal and external audits, including external contract laboratories and GMP service providers, where required. Escalates potential product quality issues. Analyzes laboratory performance and quality data for quarterly site management and annual product reviews. Provides oversight for raw material reduced testing programs. Supports the Janssen Biotherapeutics Discovery and Supply (BTDS) group through; Characterization and/or release testing for projects related to early development, clinical, and commercial products. Co-validation and/or transfer of new analytical test methods. Testing of Master, Working, and QC cell banks produced by the Janssen Cell Banking Center of Excellence (CoE). Provides input to product quality complaint investigations. Prepares for and provides QC expertise during Health Authority inspections as required. Influences senior leaders, and external colleagues/partners, across disciplines as well as globally in driving, and aligning, strategic and operational activities between business units/functions. Monitors departmental metrics and delivers reports to senior management, as necessary. Manages strategic capital projects.

Requirements

Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry or related field.
10-12 years related experience at the site/platform/enterprise
Experience directing staff, and collaborating with management from other functional areas.
Demonstrates a high level of knowledge of industry and regulatory standards and experience in interacting with Regulatory Authorities.
Experience leading cross-functional, multi-site, and/or global teams.
Advanced knowledge and understanding of regulatory requirements, including Safety, QA and QC functions, applicable cGMP compliance requirements and experience in regulatory inspections.
Experience with CAR-T therapies
Experience with FLOW cytometry, Potency assays, PCR, and ELISA.
Extensive knowledge of Biochemical and Cell based assay concepts.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data.
Strong knowledge of departments/functions which interact with Quality Control.
Strong interpersonal and communications skills; written and oral.
Expert-level understanding of new and emerging technologies and practices for regulated quality labs.
Experience contributing to regulatory submissions, including Annual Reports, Investigational New Drug (IND) filings and Biologics License Applications (BLA).
Ability to utilize standard Microsoft Office applications for word processing, communication, and data entry/ interpretation to meet business needs.
The candidate must be able to uphold our Credo Values, while driving innovation with a customer focus mentality.
This role will require interdependent partnering with all internal partners.

Nice To Haves

M.S. degree in related field preferred

Responsibilities

Manages team of people leaders and technical professionals within the QC department.
Assigns work, provides overall direction, coaches and mentors, develops capabilities and takes necessary disciplinary actions.
Responsible for overseeing and managing processes for; Ensuring adequate training (skills-based, cGMP and safety) of management and associates within the department.
Raw material, in-process, environmental/utility, product release, and stability testing.
Investigation of laboratory non-conformances (events, deviations, and invalid assays).
Maintenance, calibration and qualification of laboratory instruments and equipment.
Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
Process Performance Qualification and Continued Process Verification activities associated with QC laboratory testing.
Material evaluation/testing as part of the Supplier Material Qualification (SMQ) process.
Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Complies with all company and site policies and procedures.
Manages departmental budget and resources; prepares staffing plans.
Makes adjustments to roles and responsibilities of department to meet business needs.
Reviews and/or approves quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance investigations, CAPA, and change controls associated with the QC laboratories.
Supports internal and external audits, including external contract laboratories and GMP service providers, where required.
Escalates potential product quality issues.
Analyzes laboratory performance and quality data for quarterly site management and annual product reviews.
Provides oversight for raw material reduced testing programs.
Supports the Janssen Biotherapeutics Discovery and Supply (BTDS) group through; Characterization and/or release testing for projects related to early development, clinical, and commercial products.
Co-validation and/or transfer of new analytical test methods.
Testing of Master, Working, and QC cell banks produced by the Janssen Cell Banking Center of Excellence (CoE).
Provides input to product quality complaint investigations.
Prepares for and provides QC expertise during Health Authority inspections as required.
Influences senior leaders, and external colleagues/partners, across disciplines as well as globally in driving, and aligning, strategic and operational activities between business units/functions.
Monitors departmental metrics and delivers reports to senior management, as necessary.
Manages strategic capital projects.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year