Director, Process Development, Non-Viral Delivery

Bristol Myers Squibb • Cambridge, MA

22h

About The Position

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.

Requirements

• 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
• 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.

Nice To Haves

• Experience with late-phase process characterization is strongly preferred.
• Experience with drug product manufacturing is strongly preferred.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree