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Curia Analytical Development Analyst II in Hopkinton, Massachusetts

The Impact Is Real.

So are the career advantages.

Help connect ideas to solutions with an employer of choice: Curia.

Contribute to the creation and distribution of treatments that enhance lives. Make medicines more accessible. And help breakthroughs break through faster. At Curia, a global contract research, development, and manufacturing organization, our impact is real. So is your opportunity for a significant, satisfying career. As an employer of choice supporting the top 10 pharmaceutical companies, we offer numerous career advantages. In addition to competitive pay and meaningful benefits, you’ll enjoy the empowerment to be the difference, the chance to work with a diverse team of talented people, a culture that inspires success, and an award-winning workplace. Stop waiting for your future to arrive. Shape it every day with Curia.

We are rapidly growing and seeking a talented individual to join our Analytical Development and Quality Control Team (ADQC) as an Analytical Development Analyst II. As Analytical Development Analyst II, you will be a key contributor to the ADQC Team and be a go-to person for testing and compliance. You will report directly to the Sr. Manager of Analytical Development 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 Chemistry, Molecular, and Bioassay analytics, including HPLC, SDS page, ELIZA, potency, IEF SEC and PCR. He/she will help run methods and 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 supervision. The individual will work with various groups including Manufacturing Sciences and Technology, Quality Control, and Quality Assurance. The Analytical Development Analyst II 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 strong 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 transfer processes.

Essential Duties and Responsibilities

  • Support qualifications and execution of GMP QC methods, such as qPCR, ELISA, Potency, SDS Page, SEC, IEF and Cell-Based Assays as needed

  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements

  • Assist in equipment qualification / validation activities, including maintenance

  • Provide support to ADQC management, including routine testing, project management and lab operations

  • Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.

  • Revise SOPs

  • Provide support to audit teams for internal and vendor audits

  • Must have good understanding of laboratory instrumentation

  • Must be able to communicate effectively with supervisors and peers

    Requirements

  • BS required in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science

  • 3-5 years Quality Control experience in a cGMP organization

  • Extensive knowledge and hands-on experience performing analytical assays such as SDS-PAGE IEF, SEC and HPLC

  • Strong experience with Bioassays, ELISAs, qPCR, and other molecular biology techniques

  • Demonstrated knowledge of method and equipment

  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way

  • 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 maintaining and updating internal procedures, methods and SOPs, and the ability to track and complete multiple priorities in a dynamic environment with 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.

    FEDERAL CONTRACT COMPLIANCE

    U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.

    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.

    All interested applicants must apply online. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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