- Generous benefit options (eligible first day of employment)
- Paid training, vacation and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401k program
- Pension (for union employees)
- Learning platform
- Leads multi-faceted programs and direct others.
- In depth knowledge of analytical techniques used to characterize protein bioproducts such as titer, host cell DNA size, conformational structure, PTMs, charge variants/deaminidation, peptide mapping, glycosylation, intact mass, protein integrity, oligomeric form, epitope mapping, disulfide formation/free thiols, thermal melting points, PI, capping
- In depth knowledge of analytical techniques used to characterize RNA such as Sequence, intactness, capping efficiency, poly(A) tail length, ds RNA impurity, aggregates, %fragments, residual DNA, free nucleosides
- Oversee analytical method development, transfers, validation & operations and stability studies for critical raw materials, drug substance and drug product.
- Review and approval of relevant analytical documents including method validation protocols and reports, specifications, and comparability protocols, and provide guidance to team on various technical issues.
- Escalate significant analytical issues to management and project teams in a timely manner, drive mitigation or problem-solving activities.
- Provide technical support to clients for regulatory filings, change control and quality impact assessments.
- Develops technical plan for testing across multiple departments, external vendors and other Curia sites.
- Research and lead innovative approach for novel analytics, including publishing white papers and presenting at technical seminars.
- Keep site informed for new regulatory, ICH requirements in RNA, proteins and other biological areas.
- Build collaborative relationships with key internal team members, stakeholders (Process Development, Manufacturing, and Quality) and external customers
- Ph.D. in biological sciences, biochemistry, chemical engineering, or related field with a minimum of 8 years of relevant experience. Alternatively, a Bachelor's degree with 15+ years of relevant experience or a Master's degree with 12+ years of relevant experience will be considered.
- In depth knowledge of analytical techniques used to characterize RNA such as Sequence, intactness, capping efficiency, poly(A) tail length, ds RNA impurity, aggregates, %fragments, residual DNA, free nucleosides
- Proven track record of leading analytical development in a GMP-regulated environment and collaborating with operations and Quality teams.
- Demonstrated success in the development, transfer, qualification and validation of biologics based analytical methods using the ICH, FDA and EMA guidelines and regulatory requirements.
- Multiple years of management experience overseeing staff with a variety of skill and educational levels in CDMO environment.
- Strong knowledge of both physical analytical procedures (HPLC, ELISA, CE, MS, etc.) as well as binding assays and cell-based biological assays.
- Solid understanding and application of ICH guidelines, GMP principles, data integrity and method transfer
- Strong leadership, interpersonal communication, collaboration and problem-solving skills.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups and/or boards of directors.
- Flexible and adaptable in constantly changing environments and growing organization.
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Director; Analytical Development - Hopkinton, United States - curiate
Description
DIRECTOR; ANALYTICAL DEVELOPMENT in HOPKINTON, MA
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Director, Analytical Development will provide technical leadership and lead a team of analytical scientists in support of biologics clinical development programs. In addition, the individual will collaborate closely with internal process development, manufacturing, and quality groups as well as clients to help ensure successful delivery of programs. This position is based at Curia Biologics' manufacturing facility in Hopkinton, MA and reports to the Senior Director of Technical Operations.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.
We proudly offer
And more
Responsibilities
Qualifications
Knowledge, skills and abilities
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a email address. Curia is 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. Curia is an E-Verify employer.
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