Director, Process Development, Non-Viral Delivery

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But 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. Read more: careers.bms.com/working-with-us.

BMS is seeking a process development (PD) team leader with expertise in nucleic acid drug delivery and familiarity with employing functionalized lipid excipients and bioconjugation to enhance nucleic acid delivery via non-viral delivery vehicles such as lipid nanoparticles. This is a high-impact, high-visibility leadership role, with overall responsibility for advancing these new therapeutic models from Research into First-in-Human studies. In this role, the individual will lead a PD team overseeing early-phase development of pipeline assets, as well as aspects of late-phase PD in partnership with other late-stage development technical functions. As new drug candidate nominees emerge from the preclinical research team, the individual will be responsible for defining and developing scalable processes for their manufacture at early-phase clinical scale and for transferring these processes to clinical manufacturing to enable clinical supply. As such, the individual must be able to partner effectively with the research organization as new drug candidates emerge, delivering processes capable of incorporating novel technologies as required. This leader will also be expected to drive and influence process strategy within their domain and to participate in regulatory filing submissions. This role is based out of the BMS-Kendall Square location.

Responsibilities:

• Provide leadership and strategic direction for the non-viral delivery process development team, including growing the team if/when necessary to support pipeline needs.
• Drive the development and tech transfer of novel, best-in-class scalable processes to clinical manufacturing, in collaboration with MSAT and Quality teams.
• Deliver GLP batches of various scales to the non-clinical team, leveraging automation when prudent
• Lead scale-up and scale-down work, employing design-of-experiments and rigorous scientific methodology
• Work closely with leaders in Research, CMC strategy, PD, Product Development, analytical development, regulatory-CMC, quality, and manufacturing.
• Communicate scientifically rigorous findings via verbal and written communications, including tech transfer packages, internal presentations to key stakeholders, and external presentations when required.
• Lead, teach, and mentor junior staff to promote a culture of growth and learning.

Qualifications:

• Ph.D. in Chemical Engineering, Biotechnology, or related scientific discipline.
• A proven scientific leader with 15+ years of relevant industry experience.
• Expertise in developing processes for nucleic-acid-based therapies is essential, including nanoprecipitation, UF/DF, and bioconjugation.
• Experience in moving technology from preclinical to clinical stages is required, including MSAT experience.
• Experience owning pilot plant unit operations and producing non-clinical batches under GLP is essential.
• Familiarity with GXP and employing phase-appropriate principles is a must
• Experience with late-phase process characterization is strongly preferred.
• Experience with drug product manufacturing is strongly preferred.
• Outstanding teamwork, communication, and interpersonal skills are essential.
• Team leadership experience with a demonstrated track record of personnel development.
• Ability to adapt to increasing scope and complexity of work when required, including helping others to manage through change.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Cambridge - MA - US: $221,940 - $268,933


The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1599125 : Director, Process Development, Non-Viral Delivery