Scientist I, Analytical Development (HPLC)

Scientist I, Analytical Development (HPLC)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

The Role:

The Scientist will be responsible for developing assays for the GMP release of drug substances and drug products and will lead in product characterization activities. In addition, the Scientist will be a point person for the understanding of product behaviour throughout the manufacturing process. This will involve collaboration with colleagues across different departments of AGT.

Responsibilities:

• Develop and transfer assays for the GMP release of gene therapy products.
• Lead product characterization activities for gene therapy products.
• Troubleshoot problems that occur during release testing, process development, scale-up or in Manufacturing.
• Evaluate product testing results and support product formulation and processes.
• Report project status (development plans, timelines) to supervisor and technical teams.
• Write SOP, tech transfer and development reports.
• Keep current with all regulatory guidelines, compendia requirements, and technical innovations.
• Attend training sessions and conferences to maintain and increase skills and knowledge of cGMP’s, safety awareness and scientific knowledge.
• Follow relevant Operating Procedures.

Requirements:

• PhD with 1+ years, or MS with 5+ years, in Biochemistry with technical expertise in protein chemistry of industry experience in biopharma development with a primary focus on the characterization of proteins, viruses or other macro-biologics using standard methods.
• Proven expertise with a range of physicochemical methodologies consistent with ICH guidelines for quantifying purity/quality of proteins, viruses, and viral vectors.
• Extensive experience in separation technologies including multiple models of HPLC.
• Success designing experiments, analysing data and making decisions based on results from biophysical characterization techniques, such as CE, DLS, SEC, SEC-MALS et al, and analytical ultracentrifugation (AUC) as applied to protein and/or viral vectors.
• Prior history in compiling and analysing data and generating reports which is routinely presented to project teams to enable decision making and writing for regulatory filings.
• Success in development and transfer of characterized or qualified methodologies to manufacturing consistent with project timelines and regulatory expectations.
• Excellent communication and interpersonal skills.
• A clear and organized thought process, with attention to detail and a high-quality work ethic are essential.
• Strong work ethic with transparency and a passion for working in a fast-paced, dynamic and diverse work environment
• Ability to exercise sound judgment, tact, diplomacy, integrity and professionalism in all interactions.
• Ability to work independently without significant oversight or instruction to achieve results with a high degree of accuracy and attention to detail.
• Proven track record of excellent judgment, problem resolution, teamwork, some budgeting and/or excel skills, decision-making skills, and the ability to work under pressure required.
• Proficient in MS office suite, Empower and other work-related software.

Preferred:

• Prior AAV or Antivirus characterization and formulation experience.
• Experience with mass spectrometric analyses of biologics.

Working Environment:

• This position reports to the Head, Analytical Development.
• This position is an individual contributor role
• This position is a hands-on laboratory-based position that requires onsite work.

Salary Range: $91,000 - $130,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company-paid fleet vehicle for eligible positions
• Referral bonus program

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