About the position
Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.
Responsibilities
- Follows GMP/GLP guidelines in the acquisition and/or review of data related to method validation and/or testing of release, stability and development materials.
- May be assigned to guide others in these activities.
- Applies a phase appropriate approach to GMP in laboratory work and documentation.
- May be responsible for coordination of method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
- Operates within and maintains the laboratory in an ‘audit ready' status.
- Participates in audits and inspections.
- May contribute to the establishment and implementation of proper corrective actions for findings.
- Prepares, and may approve, reports for methods, validation, and technology transfer.
- Prepares and/or reviews operational procedures, testing protocols/reports and training materials.
- Practice and assist in implementation of best practices associated with laboratory Quality Systems including training, procedures, instrumentation management, and data and records management.
- May prepare and/or approves plans and tools for continuous improvement of quality and compliance.
- Identify deviations to quality systems or limits/specifications, and ensures they are addressed in a timely manner.
- Lead and participates in investigations, including the preparation and implementation of corrective actions (CAPAs).
- May prepare responses to questions from regulatory agencies related to analytical data and procedures.
- Effective collaboration and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.
Requirements
- Bachelor's degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 7+ years relevant industrial experience or equivalent, or Master's degree and 4-6 years of experience, or PhD and 2-4 years of experience.
- Demonstrated knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
- Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
- Experience with regulatory submissions and interaction with regulatory agency inspectors.
- Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.
Nice-to-haves
- Demonstrates ability to prioritize project responsibilities to meet competing requirements.
- Ability to adapt to change, manage multiple projects effectively meeting timelines.
- Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
- Able to identify opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
- Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
