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Job Details

GlaxoSmithKline (GSK)

Senior Manufacturing Associate



Full Time

On Site


Cambridge, Massachusetts, United States

Site Name: Cambridge Binney Street
Posted Date: Mar 10 2023

The role…

Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment. With limited supervision, responsibilities include but are not limited to having the ability to operate and perform process steps on equipment used within the manufacturing unit operations. Perform the weighing of manufacturing ingredients and the manufacturing of the intermediate formulations. Tasks include documentation, data entry, and computer software with compliant systems. Ability to perform continuous improvement actions toward safety and environmental inspections. Maintain continuous inventory control using computerized system. Must have the technical ability to interact with support groups such as facilities, process development, validations, etc., to ensure successful transfer of process changes. Must be willing and able to work in rotating shifts, extended periods, and/or overtime when required.

You will have the opportunity to…

  • Follow aseptic procedures and good documentation practices.

  • Follow production schedule to prepare and order required materials for production runs.

  • Prepare solutions per production schedule, as needed.

  • Cleaning, operating, and maintaining GMP equipment.

  • Prepare equipment for processing by performing cleaning-in-place (CIP) and cleaning-out-of-place (COP), as necessary.

  • Perform equipment inspections to ensure readiness and preventative maintenance, as needed.

  • Operate and monitor GMP equipment, adjust equipment controls, perform actions as specified by production batch records (BPRs), adhere to aseptic behaviors, and maintain a safe and clean work environment by following cGMPs.

  • Document production by completing forms, reports, logs, and records of equipment batches.

  • Maintain up-to-date training records.

  • Perform cleaning of production suites daily and as necessary.

  • Create and edit production records and documents, as necessary.

  • Work with environmental monitoring to maintain a clean and safe work environment.

  • Ability to lift up-to 20lbs.

  • Ability to troubleshoot and resolve process related issues and interact with support groups.

  • Ensure documents conform to cGMP standards.

  • Author deviations, CAPAs, and change controls as required.

  • Communicate with maintenance to ensure equipment calibrations, preventative maintenance, and non-routine work is coordinated.

  • Notify Management of safety issues and risks.

  • Provide technical training to junior employees.

  • Additional duties and responsibilities as required.

Who you are and what you bring to the team…

  • Associates degree in an area of life sciences with a minimum of 2 year of experience in manufacturing production or Bachelors’ degree in an area of life sciences with < 2 year of experience in manufacturing production required.

  • Effective oral and written communication skills required.

  • Experience or understanding of pharmaceutical development required.

  • Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations required.

  • Experience with leading and directing a team preferred.

  • Process organizational skills to ensure production batch completeness preferred.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-[Register to View] (US Toll Free) or +1 [Register to View] (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting [Register to View] site.