Shire Manufacturing Associate II in Milford, Massachusetts

Job Description:

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine/ Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

This position is focused on the biologics manufacturing of Obizur, a FDA-approved treatment for Acquired Hemophilia A, which includes processing in upstream (cell culture) and downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.

Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).

  • Strong knowledge and understanding operating manufacturing process equipment to perform various Cell Culture production steps such as: expansion of mammalian cells in roller bottles and flasks; automated and manual cell culture systems supporting cell growth, expansion and harvesting systems; viral inactivation mixing systems.

  • Strong knowledge and understanding operating manufacturing process equipment to perform various Purification production steps such as: Various filtration steps, chromatography process, and chromatography column packing activities

  • Ability to train employees on upstream activities.

  • Ability to train employees on downstream activities.

  • Proficient operating BSC’s, chromatography skids, chromatography columns, autoclave and glass washers. Ability to train employees in these areas.

  • Subject matter expert operating other production testing equipment, as needed (such as pH and conductivity meters, etc.) and record batch parameters, including computer data entry.

  • Complete relevant paperwork following GDP/GMP guidelines.

  • Perform mathematical calculations related to production processes.

  • Initiate new documents for procedures; minor edits to existing documents.

  • Work with support team on all necessary event investigations and JDE inventory system cycle counts and discrepancies process problems and respond to alarms.

  • Provide information for unplanned events, including entering data into event management software.

  • Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution.

  • Cleaning/sanitization systems (such as glasswasher and autoclave, etc.). Manually clean portable equipment and small parts.

  • Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.

  • Operating inside of a BSC, sampling, and performing with aseptic techniques.

  • Perform environmental monitoring

  • Lead Continuous Improvement Teams (such as Gemba, OMT)

  • Demonstrate procedures as a training session for team members; schedule department process

  • Provide knowledge in areas of training process improvements

Requirements:

Associate’s Degree in Life Sciences/Engineering field. Biotech Certificate preferred

Normally requires 1-4 years of related experience in the following

With HS school diploma: requires 3-6 years of experience

  • Demonstrated knowledge of CGMP; manufacturing skills in purification; Experience processes helpful but not required.

  • Requires experience of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment.

  • Proficiency in a variety of mathematical and able work both the metric USA of measurement, military time.

  • Read and follow detailed English written instructions and have good verbal/written communication skills.

  • Write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms.

  • Familiar with standard trouble shooting approaches of basic chemical and biological safety procedures.

  • Computer skills, knowledge of Microsoft Word, Excel.

  • Interpersonal skills and be able to work effectively and efficiently in a team environment.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.