Manager CRS Laboratory

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

EDUCATION and/or EXPERIENCE:

Bachelors Degree in Biology Biochemistry Microbiology Chemistry or related field.

M.S. degree in related field preferred

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.

SCOPE:

Manages team of people leaders and technical professionals within the QC department. Responsible for an organization comprised of 30-40 employees including direct responsibility of approximately 4 individuals. Participates as an active member on the Malvern site Quality leadership team. Assigns work provides overall direction coaches and mentors develops capabilities and takes necessary disciplinary actions.

• 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.

EXTERNAL AND INTERNAL INTERACTIONS:

Internal: Analytical Development Supply Chain Platform Leaders MTO Leadership Team Quality Information Technology Technical Operations Product Development J&J Production Systems COE Finance Human Resources other J&J sectors

External: Manufacturing Systems and Lab Systems Technology providers System Integrators Regulatory agencies.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

• Required to work with chemical and biological substances on a daily basis

• Required to work on feet or seated for extended periods of time in a laboratory setting

• Requires sufficient vision to adequately perform visual inspections of materials (color appearance particles etc.) and to document observations during laboratory testing

• Occasionally required to lift up to 20 pounds

• Infrequently (< 5%) required to travel to other sites/locations

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodationexternal applicants please contact us via .Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Staff Leadership

Preferred Skills:

Benchmarking Compliance Management Developing Others Human-Computer Relationships Inclusive Leadership Leadership Operational Excellence Performance Measurement Product Testing Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Standard Operating Procedure (SOP) Tactical Planning Team Management

The anticipated base pay range for this position is :

$102000.00 - $177100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

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 period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Manager