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QC Microbiology Analyst I, Analytical Development and Quality Control [JC-1430]

Company: Lake Pharma
Location: Hopkinton
Posted on: June 12, 2021

Job Description:



LakePharma is the leading US-based biologics contract research, development, and manufacturing organization (CRDMO). The company has developed a range of technologies and capabilities in antibody discovery, protein engineering, cell line development, protein optimization, and GMP manufacturing. With comprehensive technologies, integrated platforms, and five facilities located in key biopharma hubs on both the East and West Coast, LakePharma enables and supports the discovery and development of the biologics of tomorrow.

We are rapidly growing and seeking a talented individual to join our Analytical Development and Quality Control Team (ADQC) as a QC Microbiology Analyst I. As the QC Microbiology Analyst I, you will be a key liaison between the analytical and QC Teams, and be a go-to person for compliance, method and equipment qualification and validation. You will report directly to the Sr manager of QC and will be based in our Hopkinton office.

Position Summary

The ideal candidate will support cGMP method validation, equipment validation, qualification and release testing for raw materials, drug substance and finished product testing for products produced at Lake Pharma's GMP manufacturing facility and affiliated contract organizations. The individual will have a focus on Microbiology and Chemistry, including Bioburden, Endotoxin, Sterility, TOC, Environmental monitoring, PW/WFI water collection regulations, clean room experience and Micro id. He/she will develop methods, qualify and validate equipment and support investigations for OOS and other non-conforming results. He/she will contribute to the implementation of testing capabilities, related validation and qualification activities, investigations and assay/instrument troubleshooting with a high degree of independence. The individual will act as interdepartmental liaison to various groups including Manufacturing Sciences and Technology, Quality Control, and Quality Assurance. The QC Microbiology Analyst IV will be able to support and collaborate with commercial, laboratory, and manufacturing teams to ensure customer requirements are translated into appropriate specifications. The candidate will have solid knowledge of cGMP principles, ICH, USP, FDA and EU guidance documents, and quality systems. Based on your knowledge and experience, you will ensure we establish robust methods and validation procedures.

Essential Duties and Responsibilities

  • Support qualifications and execution of GMP QC methods, such as Bioburden, Endotoxin, Sterility, TOC, pH, Conductivity, Environmental monitoring, water collection and Micro id, as needed
  • Strong aseptic technique
  • Collaborate with development groups for new equipment/methods and qualifications/validations in support of expanding the cGMP QC Microbiology laboratory capabilities
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Lead equipment qualification / validation activities, including maintenance
  • As a Subject Matter Expert, troubleshoot issues related to equipment, laboratory procedures and assay performance
  • Conduct technical assessments of deviations and investigations
  • Provide support to QC management, including the coordination and scheduling of routine testing, project management and lab operations
  • Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.
  • Write/revise SOPs, protocols and reports
  • Train other laboratory staff on method execution and troubleshooting
  • Provide support to audit teams for internal, FDA and vendor audits


  • BS required or MS preferred in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science
  • Minimum of 0-3 years Quality Control experience in a cGMP organization
  • Extensive knowledge and hands-on experience performing microbiological assays such as Bioburden and Endotoxin
  • Strong experience with EM and Water qualifications and validations
  • Demonstrated knowledge of method and equipment validations and qualifications
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
  • Proven ability to conduct investigations
  • Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Excellent communication skills (verbal and written), and other electronic systems

To be successful in this role you will need experience with cGMP for biologics, experience in establishing, maintaining and updating internal procedures, methods and SOPs, and the ability to track and complete multiple priorities in a dynamic environment with minimal supervision. You're resourceful, organized and a clear communicator. You're even-keeled, upbeat, responsive and thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. You have the ability to develop productive relationships with key stakeholders, good conflict management and negotiation skills.

Work Environment

Work is performed in an office and laboratory environment. May be exposed to biological and chemical hazards. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Must be able to work while wearing personal protective equipment such as safety glasses, gloves, and lab coats deemed necessary to protect testing and to protect employees. Work is to be performed on site.


This job description is not necessarily a comprehensive list of all duties and responsibilities. The employer reserves the right to revise key functions of this position at any time.

LakePharma is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Lake Pharma, Worcester , QC Microbiology Analyst I, Analytical Development and Quality Control [JC-1430], Other , Hopkinton, Massachusetts

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