Process Development Scientist Jobs

PhD in chemistry with 0-5 years experience in the pharma industry.

Experience with applying biocatalysis in a laboratory setting.

Working experience designing and optimizing biocatalytic reactions, high-throughput screening in multi-well plates and developing new enzyme platforms.

Non-standard Work Schedule, Travel Or Environment Requirements

Responsible for coaching, mentoring, training, supervising, and developing staff when assigned; participate in recruiting when needed.

Prepares research reports and technical presentations and external publications.

Keep current with all regulatory guidelines, compendia requirements, and technical innovations.

Strong knowledge of virus, protein and DNA/RNA chemistry

Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP)

Demonstrated verbal and written skills in technical reports and documents

Experience in separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric in analyses of biologics

Experience in statistical analysis using JMP or other software

Prepare sterile reagents as dictated by procedures or management by filtration or steam autoclaving.

Reports any discrepancies from protocols/study procedures or any materials preparation problems to management.

Practical experience with FPLC (Fast Protein Liquid Chromatography)

Experience with other aspects of downstream purification (e.g. – clarification/filtration, TFF, etc.)

Experience with lab, pilot, and large-scale FPLC systems.

Experience with the purification of vaccines or viral vectors.

Offer guidance and lab-level leadership for incumbent associates, with possibility for 1-2 direct report(s)

May include approximately 20% remote work, with flexibility based on project needs

BS+8 / MS+6 / PhD+2 years minimum industry experience in a process development or MSAT role

Excellent communication and presentation skills. Capability to convey complex technical information in a clear, concise, and influential manner

Prior experience developing purification processes for virus, VLP, or gene therapy vectors for GMP clinical manufacturing.

Working knowledge of the GMP manufacturing environment, which may include involvement in process transfer, review of batch records/deviations/CAPAs, or ‘person-in-plant’ duties.

* 8+ years of Biotechnology industry experience leading upstream mammalian cell culture process development.

* Experience leading cross-functional, multi-national teams including tech transfer teams.

* Competitive base salary, target bonus, retirement allowance and excellent medical benefits.

Preferred Candidate Background and Expertise:

* MS or Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, Biology or related Life Sciences field.

* Ability to build and maintain strong, positive relationships with customers.

Extensive experience in upstream, downstream, analytical development, and continuous manufacturing for vaccines/biologics, with in-depth domain knowledge in one of these areas.

Strong knowledge of global regulatory requirements for vaccines.

Demonstrated scientific and communication capability to strongly influence senior management across functional areas and steer scientific strategy and policy.

Demonstrated expertise in addressing complex challenges in pipeline and life cycle management through critical thinking, innovation, scientific rigor, and cross-functional collaboration.

Experience in CMC or program direction, leading to multiple successful submissions for vaccines/biologics.

Working knowledge on DPI and adjuvant development and innovation.

Strong project management and organizational skills.

Leads technical support activities related to maintaining commercial product supplies through management of internal and external resources.

Knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.

Contributes to user requirement specification and provides expert process technical support to utilize and validate new and improved technologies.

Experience with statistical data analysis tools is preferred.

Excellent troubleshooting skills and ability to solve complex technical issues.

Collaborates with Process Development Scientists and Management during technical transfer and experiment design.

Responsible for reviewing executed documentation for accuracy and completeness prior to submission to management.

Assists with the implementation of Process Development strategies as directed by management

Expected to adhere to all procedures, including gowning and safety requirements, at all times

Strong oral and written communication skills

Knowledge of Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing.

Ensure compliance with regulatory requirements and safety protocols in all laboratory activities, maintaining a strong focus on quality and compliance.

Stay up-to-date with the latest scientific and technological advancements and apply this knowledge to advance product development.

Substantial experience in experimental design, execution, and data analysis within a scientific research and development environment, focusing on process optimization.

Substantial experience developing and ensuring adherence to Standard Operating Procedures (SOPs).

Outstanding analytical, problem-solving, and critical thinking skills, with a proven ability to tackle complex scientific challenges.

Excellent written and verbal communication abilities, including effectively communicating complex scientific concepts to technical and non-technical stakeholders.

Strong interpersonal skills and excellent project management, data analysis, time management and people skills together with a sense of urgency.

Support the quality management system and review for approval other quality system documents as applicable.

In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques

Manage dynamic timelines, and processes across the product development activities, specifically bioengineering and genome sequencing and cDNA hybridization.

Support all applicable regulations including but not limited to FDA, ISO, IVDR, MDCG, and CMDCAS requirements.

Minimum of 5 years of relevant industry experience and IVD assay development

Non-standard Work Schedule, Travel Or Environment Requirements

PhD. in Organic Chemistry (or within 6 months of completing Ph.D. program).

The ability to employ analytical tools, computational and statistical methodology, and automated laboratory technologies to enhance process development efficiency is desirable.

Ability to use sound scientific judgment and analyze data to advance programs.

Travel is required on occasion in support of external manufacture or to participate in scientific conferences.

How You Will Achieve It

Exceptional time management and multi-tasking skills.

Provide technical information and experimental assay design; data analysis and management; and instrument & project troubleshooting.

Supporting the Process Development team in the following: time management and prioritization

In addition to competitive compensation, we offer a comprehensive benefits package including:

Experience in development of pDNA and recombinant products for cGMP manufacturing.

Minimum 5+ years of experience in upstream or downstream PD in an advanced contributor role.

Education, Experience, Knowledge And Skills

Good time and project management skills, ability to execute or oversee several studies simultaneously.

Design, manage, lead, and execute studies pertaining to Process Development.

Lead, train, and provide work direction to other Scientists, Research Associates, and Interns. May be required to manage junior scientists.

Experience in laboratory scale process science, including process scale-up and scale-down required.

Knowledge of cGMP practices as applicable to process development, formulation, analytical development, technology transfer, or manufacturing would be a distinct advantage.

Develops and executes large-scale productions and harvest protocols. Utilizes technical knowledge to scale up to manufacturing scales.

Uphold the EHS requirements of this position.

Medical, dental and vision benefits effective day one of employment

Catalent offers rewarding opportunities to further your career!

Degree field in Chemical Engineering, Biochemical Engineering, Chemistry, or Life Science field

Ph.D. – 0-3 years; MS – 3-6 years; BS - 6-9 years

Design, execute, document, and present on small-scale experiments to improve process knowledge using statistical analysis (JMP)

Identifying technical approaches to improve process microbiology characterization study quality and efficiency

Developing a fundamental understanding of microbiological impacts to the manufacturing processes

Identifying, developing, and implementing best in class technologies for microbiological detection and characterization in manufacturing facilities

Automating of laboratory processes and data analyses

Collaborating with scientific partner groups to leverage and share insights to achieve the greatest impact

Resource planning and management skills

Support knowledge transfer to contract manufacturing sites

3-6 years of experience in regulated industry

Experience in medical device, pharmaceutical, or biotechnology industry

Knowledge of aseptic processing, device assembly, and automated inspection

Strong collaboration and problem-solving abilities

Coordinate effectively with different functional teams from Product Development, Bioinformatics, Operation, Quality, Product management, etc.

Knowledge of statistical methods and data analysis experience is required

Proven experience of working in cross-functional development teams and strong communication skills

Knowledge and experience with single cell genomics is strongly desired.

Trouble shooting skills to address customer complaints

Minimum of 3 years of demonstrated experience in R&D or research laboratory environment in genomics technologies or related field.

Ability to balance independent execution with strategic contributions and project management.

Significant experience with mammalian cell culture systems, preferably with lymphocytes

Excellent attention to detail, excellent written and oral communication skills

Experience with scalable, closed-system cell culture technologies.

Experience with molecular biology and/or cell engineering

Experience with multicolor flow cytometry and other immune related assays

Excellent communication skills, ability to work in matrixed teams and collaborate with diverse partners cross-functionally

A demonstrated ability to think critically with excellent problem solving and troubleshooting skills

In-depth understanding of cell biology/molecular biology and hands-on experience of molecular subcloning, vector design, and mammalian cell culture

Hands-on experience with RNA and whole-genome (re)sequencing, bioinformatics analysis and familiarity with genome editing tools

Knowledge of recombinant protein expression, metabolic pathways, biochemistry, and cell culture

Sound scientific knowledge of protein properties and purification

Provide general lab support and management.

Communicate project updates and technical reports to supervisor and senior level management.

Experience in protein purification along with the knowledge of AKTA systems is a must.

Experience with Octet, TFF systems, HPLC/UPLC is a plus.

SME for purification of biomolecules using mammalian and/or insect systems.

Lead direct reports in upstream process development.