Responsibilities
Location Upper Providence, PennsylvaniaUS
Job ID REQ-053430
Job Summary:
We are looking for a highly motivated candidate to lead our Process Engineering and Modeling team within the Biopharmaceutical Product Sciences (BPS) department, of the BioPharma Product Development & Supply organization. The role will center on developing drug product, manufacturing process and delivery systems for protein & peptide-based therapeutics.
Process Engineering:
- Conduct laboratory experimentation and analytical testing of putative formulations & drug product manufacturing
- Follow administration/delivery approaches for select protein therapeutic assets, including contributing to, the conception & evaluation of conventional & novel product matrices and administration modalities
- Partner closely with the manufacturing groups during process development and technology transfers
- Actively participate with combination drug product assessment and collaborate with device engineering
- Physicochemical and bioanalytical characterization of native and modified biopharma compounds
- Collaborate with the Bioanalytical Sciences group to develop & transfer stability-indicating analytical methods for use in product development
- Oversee release & stability testing; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
- Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols
- Assess resultant data; working closely with internal & external discovery and development support partners as needed
- Develop and implement chemometric process models to support process monitoring and control activities during pilot scale and commercial manufacturing.
Modeling:
- Establish Hybrid/mechanistic process models to accelerate development, increase fundamental understanding, improve risk assessment and deliver more robust processes, products and regulatory filings.
- Implement modelling and simulation directly on key projects to increase fundamental understanding and greatly reduce labor, materials and time required to identify commercial processes.
- Upskill project team members to expand the use of simulation and work with internal and external experts to development /maintain core simulation software platforms.
- Champion integration of new ways of working into existing QbD workflows (e.g. Process Design, Control Strategy Identification, Risk Assessment), regulatory filing strategies and life cycle planning.
- Provide or coordinate training and real-time support to expand the use of chemometrics and mechanistic modeling (simulation) across business modalities.
- Stay current with new modeling techniques through publications, conferences and academic and precompetitive collaborations
- Advocate and comply with GMP requirements for recording experiments and associated data and writing modeling sports including scientific review and data checking.
- Adhere to requirements of Good Manufacturing Practice, Safety, Quality for the Patient and GSK policies and procedures (sites and department).
- Provide critical support outside area of expertise if required to make sure projects meet development timelines.
Leadership:
- Mentor and train staff at client location regarding best-in-class customer support, follow up communication and specific laboratory support skills to drive growth and customer satisfaction
- Collaborate with ServiceManager to drive talent development, overall business performance, and succession planning
- Accountable for all assigned staff administrative duties; including on-boarding, work hour documentation/approval, expense report approval, time-off, etc.
- Work with Service Managerto ensure on-site team is efficiently deployed and has proper training with cross training opportunities defined
- Facilitate team lead meetings, as well as one on ones, performance reviews/evaluations
- Address disciplinary and/or performance problems when necessary in accordance with company policy
- Facilitate interviews for all new hires and ensure successful onboarding
- Identify and/or create necessary SOP's, Work Instructions and documentation to ensure you and your team carry out activities in a consistent and reliable manner.
- Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time
Basic Qualifications:
- PhD degree in Pharmaceutics, Chemometrics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 1-3 years of protein formulation and drug delivery development experience
- Mastery of mainstream chemometric techniques (multivariate classification, calibration, pattern recognition, PCA/PLS) and familiarity with design of experiments concepts and methods.
OR
- Master's degree in Pharmaceutics, Chemometrics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
- 5-7 years of similar experience in protein formulation and drug delivery development experience
- Mastery of mainstream chemometric techniques (multivariate classification, calibration, pattern recognition, PCA/PLS) and familiarity with design of experiments concepts and methods.
Preferred Experience:
- Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development, including the application of DOE and other statistically based experimental design/interpretation approaches.
- Experience with protein product manufacturing processes and development (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
- Experience and understanding of multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), DSC, particles evaluation by HIAC and/or orthogonal techniques (eg MFI, FlowCam, Archimedes), capillary electrophoresis & chip-based methods, etc.
- Experience in authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, BLA/MAA filings, response to regulatory questions, and pre-approval inspection experience.
- Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities
- Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities would be beneficial.
- Experience in the use of advanced chemometric methods for process modeling (MSPC, MCR) and 'data wrangling' for signal processing and feature extraction.
- Familiarity with other data driven machine learning methods (SVM, ANN, Bayesian modeling) or the application of hybrid empirical/mechanistic modeling.
- Experience using data analytics and modeling tools for chemical and/or biochemical processes.
- Industrial experience in one or more of the following areas: iii) biopharmaceuticals development; iv) product industrialisation and manufacturing.
- Programming experience using languages such as Matlab, Python, R or C
- Demonstrated ability to independently design and execute work plans and experimentation to support models development.
- Good interpersonal, organizational and communication skills.
- Familiarity with Quality by Design concepts, their application and ICH Q8/Q9/Q10 guidelines.
- Experience in the definition of data and informatics requirements for digital platforms supporting modeling.
Physical Demands
- Must be able to remains in a stationary position more than 25% of the time
- The person in this position needs to occasionally move inside and outside labs
- Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
- Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds
- Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
- Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer
Working Environment
- Must be able to work in a laboratory, controlled environments requiring personal protectiveequipment.
- Job pace may be fast and job completion demands may be high.
- Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling.
- Ensure safety, security, and the environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected immediately.
- Understand ergonomic relationship between people, equipment and working environment.
The annualcompensation range for this full-time position is $83,720 to $125,320. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.
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