Scientist, Downstream Process Development

Job description

Scientist, Downstream Process Development
The Scientist will be involved in designing, managing and executing laboratory studies to support early-stage development as well as IND and IMPD submissions for Hilleman’s portfolio of products.

He/she will conduct experiments to establish, optimize and qualify manufacturing methods for the production of biologics such as mRNA, Mab, recombinant proteins, bacterial-based, yeast-based and/or viral vaccines.

He/she will analyze data from studies, method development, or tech-transfer activities, and assist in authoring reports for submission to regulatory agencies.


RESPONSIBILITIES
Define and drive platform development strategy for downstream processes considering robustness, scalability and manufacturing feasibility/suitability.

This may include screening, optimization, scale-up and incorporating advanced feeding strategies as necessary, to establish robust and highly productive downstream processes for biopharmaceuticals including mRNA, MAbs, recombinant proteins, vaccines.


Conduct experimental procedures to establish, optimize and qualify downstream technologies including chromatography such as the ÄKTA system or others as suitable, membrane filtration and viral reduction.


Independently design, execute and interpret studies aimed at developing suitable process steps/ scale up/ down model and associated manufacturing processes.


Generate, manage, evaluate, and maintain critical data in a highly organized manner.


Analysis of experimental data using statistical approaches.


Author high-quality technical memorandum, protocols, reports, summaries, and quantitative analysis, for the distribution and/or presentation to project teams, and for regulatory agency submissions.


Responsible for participating in new product technology transfer, and process qualification and validation activities to advance Hilleman’s portfolio pipeline.


Support the establishment of sound system/process to structure the development activities and information management to ensure the efficient delivery of a well-organized data package for IND- and IMPD-enabling development.


Interface with contract manufacturing and testing organizations (CMOs and CTOs) to achieve projects deliverables within the specified timeline.


Partnership in a matrix approach to ensure Process Development activities are fully supported and aligned with other functional groups such as Analytical Development, Project Management, Drug Product Development and Quality Assurance to advance the programme.


Evaluate and implement new technologies for downstream process development.


Propose and implement resolutions to technical problems/issues.


Support local initiatives as directed by supervisor and participate in departmental or cross-departmental initiatives as appropriate.


To achieve deliverables in a timely fashion.


To support and participate in daily laboratory operations, maintenance and all other duties as required.


EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
PhD in Biochemical Engineering, Biotechnology, Biochemistry or related discipline with a minimum of 2 years relevant industry experience (may include post-Doctoral experience), MSc in a scientific discipline with a minimum of 4 years relevant industry experience, or a BSc in a scientific discipline with a minimum of 6 years relevant industry experience.


Hands‐on experience and knowledge with chromatography, membrane filtration, viral reduction, process techniques and equipment as related to biopharmaceutical process development at bench scale to pilot scale, is essential.


Experience in practical laboratory in protein purification of biologics and biopharmaceuticals such as Mab, recombinant proteins, bacterial and/or viral vaccines.


Recent experience with early‐stage development of biologics or viral vector products, with familiarity in establishing QbD approach, as well as IND & IMPD-enabling studies will be an advantage.


Experience/knowledge of cGMP practices as applicable to downstream manufacturing processes for microbial and mammalian cell culture derived biopharmaceuticals, process development and/or technology transfer is desirable.


Strong problem‐solving and risk‐based decision‐making skills for project advancement.


Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, fast‐paced environment.


Experience with Statistics and Design of Experiment (DoE) as applied in an industrial biopharmaceutical environment will be a distinct advantage.


Highly motivated team player capable of independent work with initiative and drive.


Excellent communication skills with the ability to present ideas, information effectively and work collaboratively as a member of a multidisciplinary team.


Comply with laboratory safety practices and standard operating procedures.


Schedule flexibility including weekend and occasional off‐hours coverage.


PHYSICAL DEMANDS
Manual dexterity required to operate office equipment (ie.

computers, phones, etc.).


Typical laboratory bending, stooping, lifting requirements apply.


Lifting and moving supplies and equipment (up to 20kg).


Ability to wear PPE.


TRAVEL REQUIREMENTS
Willingness to travel to various meetings or client sites, including overnight trips.

Some international travel may be required.

Approximately 5 – 20%
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