Scientist II – Oligonucleotide Process Development, Manufacturing Development and Scale-Up

JOB DESCRIPTION:

Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution.

• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

The Opportunity
The Scientist IIrole works out of our Carlsbad CA location in the Infectious Disease Division at Abbott. Were empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day more than 10 million tests are run on Abbotts diagnostics instruments providing lab results for millions of people.

What Youll Work On

We are seeking an Oligonucleotide Scientist with responsibilities spanning Process Development Manufacturing Development and Scale-Up of solid-phase oligonucleotide this role you will execute research develop and optimize oligonucleotide processes across the full development lifecycle from early feasibility runs through process characterization tech transfer and scale-up. You will work hands-on with automated synthesizers develop and refine synthesis cycles troubleshoot complex chemistries and drive scale-up from nano-gram process development to micro/milli-gram scale-up. This is a high-impact role for a scientist who enjoys solving problems at the intersection of organic chemistry analytical science and process engineering. The scientist will also Independently develop data presentations for use within organization.

• Design and execute solid-phase oligonucleotide synthesis on automated synthesizers (e.g. ÄKTA Oligosynt ÄKTA Pilot 100 GE/Cytiva flow-through platforms) using phosphoramidite chemistry.

• Develop optimize and document synthesis cycles including coupling capping oxidation/sulfurization and detritylation steps and tune cycle parameters (reagent equivalents contact times flow rates) for each scale and chemistry.

• Support scale-up from process development (PD) to engineering and GMP production batches including selection of solid supports (CPG polystyrene UnyLinker) columns (e.g. SYC FineLINE) and reagent footprints.

• Synthesize complex modified oligonucleotides including phosphorothioate (PS) backbones 2-OMe 2-MOE LNA and other relevant modifications.

• Characterize crude and purified product by analytical UPLC IEX-HPLC RP-HPLC and LC/MS; interpret mass spectra to identify and quantify related impurities (n1 n1 depurination longmers shortmers branched species oxidation/sulfurization products).

• Troubleshoot synthesis failures and impurity profiles drive root-cause investigations and implement process improvements.

• Author and review technical documents protocols batch records development reports deviation investigations and tech-transfer packages.

• Partner cross-functionally with Analytical Development Downstream Processing/Purification Quality Manufacturing and Regulatory teams.

• Maintain a safe clean and compliant lab environment in accordance with company SOPs and applicable cGMP/ICH guidelines.

Required Qualifications

• Hands-on experience with solid-phase oligonucleotide synthesis using phosphoramidite chemistry.

• B.S in biological or physical sciences or mathematics; with minimum of 4 yrs.

• M.S. w/ minimum 2 yrs experience. Or Ph.D.

• Direct experience operating at least one automated oligonucleotide synthesizer.

• Working knowledge of common solid supports (CPG polystyrene UnyLinker) and the relationship between support loading column geometry and synthesis scale.

• Hands-on experience with LC/MS for oligonucleotide characterization with demonstrated ability to identify and quantify related impurities (n1 n1 depurination longmers shortmers branched species oxidation/desulfurization products) and to perform sequence confirmation by MS/MS fragmentation.

• Familiarity with complementary oligonucleotide analytical techniques: UPLC/HPLC (RP and IEX) for purity assessment.

• Strong scientific writing and documentation skills.

• Ability to work independently prioritize multiple projects and meet deadlines in a fast-paced environment.

Preferred Qualifications

• Experience in a GMP or pharmaceutical API manufacturing environment.

• Experience operating Waters LC/MS systems (e.g. Xevo SYNAPT ACQUITY-MS) and associated data-processing software (MassLynx UNIFI).

• Experience with scale-up (nmol to mmol scale) and tech transfer of oligonucleotide processes.

• Familiarity with conjugated oligonucleotides (e.g. lipid conjugates).

• Experience with downstream operations cleavage/deprotection IEX or RP preparative purification ultrafiltration/diafiltration and lyophilization.

• Familiarity with statistical tools (JMP Minitab) and Design of Experiments (DoE).

• Awareness of regulations and standards affecting IVDs and Biologics

• Basic computer skills - able to learn new computer programs

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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