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
- Support the pharmaceutical manufacturing equipment cleaning verification (CV) activities.
- Development/validation of Total Organic Carbon (TOC) and Liquid Chromatography (HPLC) methods.
- Conducting and reviewing CV sample analysis.
- Authoring CV method/validation reports and performing change control associated with the method revisions.
- Investigate and resolve cleaning-related issues, deviations, and nonconformances.
- Maintenance of TOC/HPLC instruments.
- Assess impacts to CV testing as a result of clinical manufacturing and compound permitted daily exposure limit changes.
- Collaborate with clinical manufacturing for periodic procedure revisions and assessment of risks.
- Perform analytical cGMP activities and provide technical expertise for evaluation and feedback of methods.
- Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., cGMP, ICH) related to cleaning verification.
- Provide technical expertise and troubleshooting for technical problems and investigations.
- Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to ensure effective cleaning processes.
- Participate in the preparation and critically review of regulatory filings including evaluation of data from collaborator labs.
- Stay current with industry trends, advancements, and regulatory changes related to cleaning verification.
- Technology transfer of analytical methods to external BMS partners.
- Provide input into audit readiness and expertise for internal and regulatory inspections.
- 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
- Bachelors degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 9+ years relevant industrial experience or equivalent, or Masters degree and 6-9 years of experience, or PhD and 4-6 years of experience.
- Extensive pharmaceutical equipment cleaning verification knowledge and 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 multidisciplinary teams.
- Experience with notebook review and regulatory submissions.
- Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.
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.
