Scientist II, Analytical Development

Responsibilities :

• Develop and transfer assays for the GMP release of gene therapy products.
• Collaborate with research group to develop first-in-class drugs.
• Lead product characterization activities for gene therapy products.
• Troubleshoot problems that occur during product early-stage development, 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 tech transfer and development reports.
• Keep current with all regulatory guidelines, compendia requirements, scientific publications, and technical innovations.
• Attend training sessions and conferences in order to maintain and increase skills and knowledge of cGMP’s, safety awareness and scientific knowledge.
• Follow relevant Operating Procedures.

Organizational Context :

• This position reports to the Lead, Analytical Development.
• This position is an individual contributor role.
• This position requires onsite work.

Requirements

Required Qualifications :

• PhD with 3+ years, or MS with 10+ years, in Biology with industry experience in biotech / biopharma companies with technical expertise on viruses, proteins, DNA and other macro-biologics using standard methods.
• Proven expertise with protein drug research and development.
• Extensive experience in viral, cell and molecular biological technologies including but not limited to cell-based assay, DNA cloning, PCR, ELISA, Western etc.

Expertise with range of biological methodologies consistent with ICH guidelines for quantifying purity / quality of viruses, proteins or DNA.

• Success designing experiments, analyzing data and making decisions based on results applied to viral vectors, protein and DNA is required.
• Prior history in compiling and analyzing data and generating reports which is routinely presented to project teams to enable decision making and writing for PD process change & regulatory filings.
• Success in development and transfer of qualified or validated methodologies to QC and manufacturing consistent with project timelines and regulatory expectations.
• Experience in technical leading and supervising research associates to perform experiments.
• 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 keep current with regulation guideline, compendia requirement, scientific publications, and innovative technologies.
• 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 and work-related software.

Preferred Qualifications :

• AAV experience.
• Familiar with viral vector design.
• Protein engineering and modification.

Working Conditions :

This position is a hands-on laboratory-based position that requires onsite work.

Salary Range : $114,800 - $153,000 (NOTE : Final salary could be more or less, based on experience)

Benefits :

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 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
• Referral bonus program

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.