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Sr. Specialist, Manufacturing Operations

Semma Therapeutics

Semma Therapeutics

Operations
Boston, MA, USA
Posted on Wednesday, April 24, 2024

Job Description

General Summary:

Vertex Pharmaceuticals Inc. has established a state-of-the-art GMP manufacturing facility in Boston less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical development to commercialization.

The Senior Specialist will be responsible for performing manufacturing for all phases of manufacturing including dispensing, sifting, bulk packaging, and assembly, operation, disassembly, and cleaning of equipment. This position may require working extended or alternate hours or overtime depending on the manufacturing schedule.

Key Duties and Responsibilities:

The primary responsibility of the Senior Specialist will be to manufacture clinical and commercial oral dosage small molecule drug product using traditional small molecule manufacturing techniques including granulation, compression, and film coating and includes the following responsibilities:

  • Following batch records, SOPs, and work instructions to ensure compliant operation
  • Manufacturing of commercial, clinical, and development drug products
  • Set up, Disassembly, and Operation of process equipment
  • In-process cleaning of equipment and process rooms
  • Cleaning of fixed process equipment in process rooms
  • Dispensing, sifting, and bulk packaging of clinical and commercial products
  • Assessment and escalation of non-conformances
  • Writing and revising manufacturing documentation
  • Owning and assessing change controls

Education and Experience:

  • Bachelor’s degree and a minimum of 2 years experience or the equivalent combination of education and experience in a related field.
  • Previous experience in a CGMP manufacturing environment required

Required Skills:

  • Ability to lift up to 50lbs, visual acuity, manual dexterity, and ability to distinguish between the colors red, yellow, blue, and green
  • Ability to stand for extended periods of time
  • Knowledge of CGMP requirements for manufacturing
  • Solid organizational, interpersonal, communication, and documentation skills
  • Ability to follow written and oral instructions in English
  • Basic computer skills and ability to learn new systems

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite

Company Information

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.