Senior Manager, CTO Network QA Disposition at Bristol-Myers Squibb

Summit, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Cell TherapyIndustries

Requirements

Expertise in drug product disposition, including oversight of final release, review, and approval of site-specific procedures and GMP documentation in accordance with BMS policies, standards, procedures, and global cGMPs
Leadership experience in managing a team responsible for timely and accurate delivery of disposition requirements, maintenance and review of disposition-associated SOPs, and support of APQR generation
Subject Matter Expert level knowledge in disposition for cell therapy products in commercial and clinical manufacturing
Ability to oversee generation of disposition certifications (e.g., Certificate of Analysis (CoA), Dose, RFI certificate)
Experience driving assessment of disposition inputs (e.g., manufacturing batch records, QC testing, change controls, deviations, complaints, investigations, environmental monitoring results, CAPAs)
Proficiency in overseeing and approving SOPs, procedural documentation, job descriptions, training, hiring, developing, counseling, managing, motivating staff, and administering performance appraisals
Capability to assure product quality and compliance through enforcement of QA policies and procedures
Skills in communicating lot disposition status at site and network levels, compiling and presenting disposition metrics to senior management
Experience supporting regulatory inspections or audits, including direct interaction with inspectors/auditors and writing/reviewing responses
Availability for 2nd Shift: Tuesday - Saturday, Onsite Afternoon Shift, 2 p.m. - 10:30 p.m

Responsibilities

Oversight and implementation of the Drug Product disposition program at the S-12 Summit West facility
Oversee generation of all disposition certifications (e.g., CoA, Dose, RFI certificate)
Drive and oversee timely and efficient assessment of all disposition inputs (e.g., manufacturing batch records, QC testing, change controls, deviations, complaints, investigations, environmental monitoring results, CAPAs) prior to release
Oversee and approve all SOPs and procedural documentation related to the Drug Product Disposition program
Update and procure approval of job descriptions for department personnel; perform and oversee training
Hire, train, coach, develop, counsel, manage, motivate disposition personnel; write and administer performance appraisals
Assure product quality and compliance by enforcing QA policies and procedures; ensure required processes, procedures, systems, and resources are in place for compliant disposition of cell therapy products
Communicate and update lot disposition status at site and network levels
Oversee compilation of and present disposition metrics to senior management
Support site and functional teams during regulatory inspections or audits, including direct interaction with inspectors/auditors and writing/reviewing responses
Represent the S-12 facility in network initiatives

Skills

GMP

cGMP

SOP

APQR

Quality Assurance

Drug Product Disposition

Drug Product Release

QA Review

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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