Senior Scientist, Modeling & Simulation
Upper Providence, Pennsylvania
ResponsibilitiesLocation Upper Providence, PennsylvaniaUS Job ID JR-031805
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 16,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
We are looking for a highly motivated candidate to join 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.
- Develop and implement chemometric process models to support process monitoring and control activities during pilot scale and commercial manufacturing.
- 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.
- Create and maintain key chemometric platform.
- 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.
- Use engineering, chemical and / or biological knowledge to postulate mechanisms for chemical and biological processes and develop or modify existing mathematical models to describes those mechanisms.
- Translate chemometric and mechanistic models to computer models using software platforms (e.g. Unscrambler/Process Pulse, SIMCA, gPROMS, ASPEN and Dynochem) or by writing custom programs (Using Matlab, Python, C++ etc..)
- 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.
- Ability to multi-task and manage workload independently
- Ability to work within a team and communicate effectively
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time
Job Requirements and Qualifications:
Basic Qualification: (Required Education & Experience)
- Master’s degree in Chemometrics, Chemical or Biochemical Engineering or a related subject with emphasis on data analytics/chemometrics and process modeling.
- Mastery of mainstream chemometric techniques (multivariate classification, calibration, pattern recognition, PCA/PLS) and familiarity with design of experiments concepts and methods.
- 3-5 years of experience in protein formulation and drug delivery development
- Demonstrated knowledge of a broad range of chemometrics/modelling techniques
- 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.
- 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
- Must be able to work in a laboratory, controlled environments requiring personal protective equipment.
- 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.
PerkinElmer 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 or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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