Senior Scientist, Process Development - Downstream

Location
Durham, NC, US
Posted
May 23, 2021
Ref
5988
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Senior Scientist, Process Development - Downstream, is a technical lead that supports laboratory operations in process design, experimental design and execution, scale model development and management, investigational testing for manufacturing operations support, platform development project planning and execution and therapeutic product program development support.

Responsibilities

\u2022 New process design, process proof of concept through characterization studies in alignment with program strategy, pre-clinical materials generation, direct clinical and commercial GMP operations support, scale-up studies, scale model demonstration through qualification, raw materials and process pool evaluations, and process optimization and improvement studies. \u2022 Laboratory operations support process development activities for drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, as well as media and buffer manufacturing.\u2022 Advances complex downstream process development efforts as a technical lead within a cross-functional team across sites.\u2022 Leads multiple, complex, projects within the downstream unit to enhance manufacturing AAV purification technologies, capabilities, and processes.\u2022 Independently leads the design, execution, and interpretation of development studies and larger projects related to process development and scale-up, ensuring studies balance time and resources, in support of process development activities supporting related to investigational, clinical and commercial gene therapy programs. \u2022 May lead a team of downstream scientists to support the project needs.\u2022 Collaborates in multiple technical development areas. \u2022 Present proposals / results in support of assigned projects to lead progress within the department and cross-functionally.\u2022 Leads the support of active pre-clinical, clinical and commercial manufacturing through laboratory studies designed to illuminate fundamental process performance (e.g. NOR & PAR setting, CPP edge of failure, impurity clearance performance).\u2022 Leads and Authors technical reports of studies in support of process development activities such as Tech Transfer, unit operation design through characterization and Quality attribute impact assessments.\u2022 Ensures all documentation and reports for self and assigned team members are accurate, complete, and suitable for use in support of platform development summary reporting, manufacturing records development as well as Quality investigations and regulatory dossiers.\u2022 Analyzes and interprets experimental data from process studies aimed at building fundamental process understanding.\u2022 Troubleshoots highly complex scientific and technical challenges, and leads teams to their resolution.\u2022 Leads and mentors junior colleagues while fostering a team environment committed to the principles of scientific excellence.\u2022 Completes requisite training, as well as applicable policies and procedures, related to the job function.\u2022 May advise on the activity of scientific and engineering staff.\u2022 Other relates duties as assigned.

Qualifications

\u2022 Bachelor's with 8 years' experience or Master's with 6 years' experience or PHD with 4 years' experience.\u2022 Demonstrated comprehensive, high level of experience and expertise with independently leading experimental design, execution, and interpretation (Design of Experiment a plus) that drives downstream project progress and with laboratory biosafety practices. Lean laboratory implementation (e.g. 6S) a plus.\u2022 Demonstrated Comprehensive, high level of experience and expertise with the majority of biopharmaceutical purification processes such as chromatography, depth filtration, precipitation & flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance.\u2022 Demonstrated Comprehensive and high level of experience and expertise in the laboratory setting with single use and automated systems (e.g. Mobius, AKTA).\u2022 Knowledge and understanding of viral particle purification in clinical and commercial manufacturing settings, direct experience in those environments highly preferred.\u2022 In-depth knowledge of AAV development including empty/full capsid separation development, scale-up, and increasing step yield performance preferred.\u2022 Demonstrated Comprehensive and high level of experience and expertise in developing and optimizing downstream manufacturing process steps and performing and performing scale-up and down biopharmaceutical processes, including developing and leveraging scale models.\u2022 Demonstrated experience applying Understanding of and experience with global regulations pertaining to cGMP manufacturing of Drug Substance and/or Drug Product to the translation of those regulations into process development work products, specifically within the downstream context. Experience with CMC portions preferred.\u2022 Demonstrated experience as Technical downstream lead, and participation on, complex, multi-disciplinary technical teams of scientists and engineers tasked with rapid and comprehensive development of new biopharmaceutical manufacturing platforms. \u2022 May require up to 25% travel.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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