Pharmaceutical Process Development Manager Jobs

Job Description General Summary: Vertex is seeking a talented individual to join our Process Development team as a Scientist. The primary focus of this role is to lead and manage the execution of development studies for a cell-based drug candidate designed to treat diabetes. This is a full-time position based in our Boston, MA facilities, with occasional weekend work required. The Process Development group offers a fast-paced and high energy environment. The right candidate will be a subject matter expert in bioprocess engineering and have a solid technical operations background.

• Design and execute experiments to develop robust manufacturing processes for cell therapy products and implement to support programs in clinical development.
• Mentor team of bioprocess scientific associates who will work closely together within a highly matrixed, cross-functional team to deliver program goals.
• Communicate effectively between departmental teams to develop plans for ongoing studies, including understanding experimental goals, developing schedules, and delegating work to the team.
• Develop expertise in pluripotent stem cell culture and differentiation to support process development, optimization, and characterization.
• Use engineering principles to develop solutions for technical issues with high degree of complexity.
• Document experimental procedures and results according to established guidelines in electronic lab notebook.
• Perform statistics and advanced analytics on experimental data.
• Communicate progress against plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.
• Collaborate effectively within departmental teams, engage in team discussions to resolve issues, and lead projects with a fully integrated team to facilitate successful outcomes.
• Coordinate long-range priorities and resources for own team, contributing to the overall goals of the department.
• Generate and review protocols and technical reports.

• Expertise in cell culture process development for biologics and/or cell therapy products, including the independent design, execution, analysis, interpretation, and documentation of studies.
• Expertise in bioreactor process control, SCADA systems, bioreactor design and scale up principles.
• Proficiency in the application of online and inline analytical tools, bioreactor feeding technologies, and unit operations such as continuous centrifugation, buffer exchange, and filtration systems.
• Experience with a range of cell processing devices and bioreactor platforms/scales such as spinner flasks, fixed bed reactors, stirred tank reactors, and AMBR systems.
• Strong verbal and written communication skills, with excellent organizational skills and attention to detail.
• Demonstrated ability to collaborate effectively on cross-functional projects, manage multiple priorities, and adapt to changing timelines and business needs.
• Proficiency in design of experiments (DOE) and statistical analysis using statistical tools such as JMP.
• Proficiency in aseptic technique.
• Working knowledge of GMP requirements and their application to process development activities.
• Experience with pluripotent stem cell culture in both adherent and suspension formats preferred.

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biology or related discipline.
• Requires a Bachelor's degree and 6+ years of experience or a Master's degree and 3+ years of experience or a PhD and 0-3 years of experience, or the equivalent combination of education and experience.

$104,000 - $156,000

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States.

Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases—cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia— and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram.

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.