Pharmaceutical Process Development Specialist

1 week ago


Cambridge, Massachusetts, United States Yoh Full time

**Overview:**

We are seeking a skilled Process Development Scientist for a contract opportunity with Yoh Scientific's client in Cambridge, MA.

This position is in the production lab of a major pharmaceutical company and requires a master's or bachelor's degree in a scientific field, along with industry experience with process characterization, process development, scale-up experience, and assay development preferred.

**Job Summary:**

As a Process Development Scientist, you will perform design and execution of experiments to support process development of advanced novel vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.

You will also perform process characterization / process development studies, data analysis, and support the development of new processes or improve existing processes using scientific expertise, literature review, or by seeking inputs from Subject Matter Experts.

Additionally, you will complete archiving of raw and processed data as per Company policy, operate and maintain designated lab equipment, train others as needed, and complete documentation of experimental results as per GMP/GLP regulations.

**Responsibilities:**

  • Perform design and execution of experiments to support process development of advance novel vaccine programs from preclinical through clinical stages with minimal supervision, maintaining good scientific practice.
  • Perform process characterization / process development studies for the MAPS program.
  • Perform data analysis from process characterization / process development studies.
  • Support the development of new processes or improve existing processes using scientific expertise, literature review or by seeking inputs from Subject Matter Experts.
  • Support Tech transfer of developed processes to support GMP manufacturing.
  • Complete archiving of raw and processed data as per Company policy.
  • Operate and maintains designated lab equipment and train others as needed.
  • Complete the documentation of experimental results as per GMP/GLP regulations.
  • Complete the authoring of technical reports in collaboration with QA / RA / MSAT / ARD teams at GSK and assist in submission to regulatory agencies such as FDA.

**Requirements:**

  • Masters/Bachelors in related fields such as Biochemistry/Biology/Molecular Biology/Chemical Engineering with 1+ years' experience.
  • Industry experience with process characterization, process development, scale-up experience, and assay development preferred.
  • Experience in DOE and JMP software preferred.
  • Similar experience in protein purification and chromatography experience will be considered.
  • Independent, detail-oriented, and organized with excellent oral and written communication skills.
  • Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.
  • Able to maintain written records in the form of laboratory notebooks.

**Benefits:**

  • Medical, Dental & Vision Benefits.
  • 401K Retirement Saving Plan.
  • Life & Disability Insurance.
  • Direct Deposit & weekly ePayroll.
  • Employee Discount Programs.
  • Referral Bonus Programs.

**Estimated Salary Range:** $50 - $53.06 per hour depending on experience, W2.



  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About Takeda PharmaceuticalTakeda Pharmaceutical is a patient-focused company that aims to transform patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job Description:Takeda Pharmaceutical is seeking a skilled Process Development Expert to join our team. As a key member of our Synthetic Molecule Process Development (SMPD) group, you will be responsible for developing robust, sustainable, and cost-effective processes for the manufacture of new synthetic molecule pharmaceuticals.You will work closely with...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job SummaryWe are seeking an experienced Global Pharmaceutical Science Director to lead our team in the field of analytical controls and compliance. As a key member of our organization, you will be responsible for developing and implementing strategies to control quality of drug substances and products based on current Good Laboratory/Manufacturing Practice...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job OverviewTakeda Pharmaceutical is seeking a highly experienced and skilled professional to lead our Pharmaceutical Sciences team. As Global Lead, you will be responsible for overseeing the development of analytical controls and compliance programs, as well as managing global CMC programs.


  • Cambridge, Massachusetts, United States Yoh Full time

    Job Title: Process Development Scientist for a Pharmaceutical Contract Opportunity in CambridgeAre you an experienced scientist looking to expand your skills and knowledge in process development? We have a 12-month contract opportunity available with our client, a major pharmaceutical company located in Cambridge, MA.About the Job:This role involves...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full time

    ResponsibilitiesWe are looking for a Process Engineering Manager to join our team in Cambridge, MA. As a key member of our Process Engineering group, you will be responsible for developing and leading complex projects, driving technical strategy, and mentoring junior engineers.With a strong background in chemical engineering and pharmaceutical industry...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full time

    About the RoleWe are seeking an exceptional Associate Engineering Fellow to join our team in Cambridge, MA. As a key member of our Process Engineering group, you will be responsible for developing and leading complex projects, driving technical strategy, and mentoring junior engineers.With a strong background in chemical engineering and pharmaceutical...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job OverviewTakeda Pharmaceutical is a leading biopharmaceutical company dedicated to delivering innovative medicines to patients worldwide. As Senior Manager of Analytical Development, you will play a crucial role in leading our team of experts to develop and implement cutting-edge analytical methods for the production of high-quality pharmaceutical...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Embark on a challenging career opportunity with Takeda Pharmaceutical as we seek an experienced Director of Global Analytical Development to lead our team in Cambridge, MA.Job OverviewWe are looking for a highly skilled and motivated individual to oversee the development of analytical control systems, ensuring compliance with regulatory requirements. The...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full time

    Job DescriptionThis is an exciting opportunity for a Senior Process Engineer to join our team in Cambridge, MA. As a key member of our Process Engineering group, you will be responsible for developing and implementing process engineering strategies, collaborating with cross-functional teams, and overseeing process scale-up activities from laboratory to...


  • Cambridge, Massachusetts, United States LanceSoft, Inc. Full time

    LanceSoft, Inc. is seeking a skilled Process Development Specialist to join our team in Cambridge, MA.The estimated salary for this position is $80,000 - $110,000 per year, depending on experience.Job Description:We are looking for a detail-oriented and organized individual with a strong background in process development and scientific expertise to support...


  • Cambridge, Massachusetts, United States United Software Group Full time

    Job Title: Business System AnalystDescription:This role is critical to bridging the gap between business needs and technical solutions, ensuring that IT solutions align with business strategies, objectives, and processes. The ideal candidate will possess a blend of technical, analytical, and interpersonal skills, with a strong understanding of the...


  • Cambridge, Massachusetts, United States Yoh Full time

    Exciting Process Development Opportunity in Pharmaceutical IndustryWe are seeking a skilled Process Development Scientist to join our team at Yoh's client located in Cambridge, MA.This 12-month contract opportunity is in the production lab of a major pharmaceutical company and requires a strong background in process characterization, process development,...


  • Cambridge, Massachusetts, United States United Software Group Full time

    United Software Group**Overview:**United Software Group is a leading software development company that delivers innovative solutions to the pharmaceutical industry. We are seeking an experienced Pharmaceutical Business Systems Architect to join our team and contribute to the design and implementation of cutting-edge systems.**Salary Range:** $120,000 -...


  • Cambridge, Massachusetts, United States AbbVie Full time

    About the RoleWe are seeking an experienced Lead Analytical Scientist II to join our team at AbbVie in Cambridge, MA. As a key member of our global analytical scientific organization, you will be responsible for leading a team of analytical scientists and collaborating with cross-functional partners to develop innovative pharmaceutical products.Key...


  • Cambridge, Massachusetts, United States Takeda Full time

    Job DescriptionThis is a senior leadership role within the Pharmaceutical Science organization at Takeda. The Senior Director will be responsible for leading and developing a global team of managers and scientists in the field of analytical controls and compliance.Key Responsibilities:Lead and manage a global team of managers and scientists in analytical...


  • Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    About the RoleWe are seeking an experienced Administrative Support Specialist to join our team in Cambridge, Massachusetts. As an Admin Assistant II, you will provide administrative support to senior level personnel and contribute to the success of our pharmaceutical industry clients.Job ResponsibilitiesProvide advanced administrative support, including...


  • Cambridge, Massachusetts, United States Kalvista Pharmaceuticals Inc Full time

    Job OverviewKalVista Pharmaceuticals Inc is seeking an experienced Finance Director to partner with the Commercial organization, driving financial planning and analysis. As a vital member of our team, you will play a key role in supporting all financial aspects of the Commercial function.About UsKalVista Pharmaceuticals Inc is a global pharmaceutical company...


  • Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Unlock Career Opportunities in Vaccine DevelopmentWe are seeking an experienced Process Development Scientist to join our team at Proclinical Staffing, a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.Estimated Salary: $45 - 55 per...


  • Cambridge, Massachusetts, United States LanceSoft Full time

    LanceSoft is seeking a seasoned Medical Development Specialist to join their team. With a focus on bringing forward new therapeutic approaches for patients with rare and complex diseases, this role offers a unique opportunity to make a meaningful impact.Key Responsibilities:Support the maintenance of marketed products through regulatory filings,...