MSAT Engineer

MSAT Executive

Associate I, Quality Operations

Innovation Lead/ Research Scientist II

QC Chemist I

Responsibilities:Demonstrates expertise in Scale Up and Technology transfer of multiple animal stem cell product from pilot to Commercial scale (upto 1KL Stainless steel bioreactor)Co-ordinates with the R&D team (or client for tech transfer of processes) to ensure processes for GMP manufacture are robust, scalable, and suitable for the GMP specific equipment.Application of cutting-edge technologies (perfusion process) in manufacturing setup and evaluation of different manufacturing modalities.Ensures that all tech transfers into operations are controlled and implemented within GMP regulatory guidelines.Ensures the availability of appropriate SOPs and documentation are provided to enable right first time and on time delivery of customer tech transfer projects.Leads in consistent and document compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity, quality and best practice requirements.Technical point of contact (PoC) for clients for technology transfer into GMP manufacture and strong understanding on Upstream process, Process analytical tools (PAT) and analytical testing.Works closely with other departments including R&D, GMP Operations, bioengineering, and procurement as tech transfer lead to support the transfer of new processes and products into inhouse / client’s GMP manufacturing facilities.Leads in strategic resource and capacity planning for the site.Coaches junior team members to deliver high quality technical input for transferring production processes to GMP manufacturing.To keep up to date with regulatory guidelines to ensure suitability of processes for GMP and author regulatory documents for submission to Regulatory agencies (USFDA, EMA, MHRA) for animal stem cell products along with query response to agencies.Utilize technical knowledge to lead to process deviation investigations, impact assessments and reports.Supports GMP Operations and Bioengineering with fit assessments/gap analyses of equipment, facilities and processes Requirements:Hands-on experience with stainless steel production bioreactors operation, maintenance, and related control software such as Sartorius/Cytiva/Tofflon/Truking or similar systems is a must.Experience in tech transfer of fermentation production processes - fed batch, perfusion and continuous fermentation.Experience with process scale up and scale down is a must.Developing different approaches to manufacturing processesImplementing new technologies and approaches to develop new products, improve efficiency and scale up the production of cultivated foodProven experience independently troubleshooting fermentation production batches.Actively engage in safety risk assessments and process risk assessments to identify mitigations and solutions to problems which may adversely impact the process.Material assessments and bill of materials for use in GMP manufacturing.Contribute to writing and reviewing process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to GMP manufacturing.Supervision/management of team members and Effective organization, communication, and leadership skillsAbility to adjust to dynamic environment of start-ups and willingness to assist other departments. Good to have Skills:Previous experience working in a start-up/established, biopharma/ food business is a plus. Educational qualification:Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology or Microbiology, Bioprocess development, Biotechnology or related field, with 10+ years or M.Sc. with 12+ years of relevant industrial hands-on experience

Responsibilities:Assist in setup, operate and monitor fermentation processes ranging from 10L to 1KL and also operate associated sensors and GMP equipmentsAssist in developing strategies to improve the overall reliability and productivity of fermentation processes.Preparing and maintaining fermentation cultures and media in a sterile environment, following standard operating procedures (SOPs) for sterilization and cleanliness proceduresMonitoring production equipment in GMP during fermentation processes to ensure that it is functioning properlyMonitoring equipment such as cell counters, pH meters, osmometers and pressure gauges to ensure that fermentation conditions are within safe ranges at all times.Maintenance of equipment in GMP such as incubators, LN2 containers, shakers, stirrers, refrigerators and freezers.Maintaining detailed records of fermentation processes and batches, including cell density , cell viability, temperature and pH levels, pO2 levels, agitation, aerations and other factors.Handle and protect confidential and sensitive data with integrity.Perform related work and other duties, as assigned.Requirements:Knowledge on stainless steel production bioreactors operation, maintenance, and related control software.Knowledge on developing fermentation production processes including batch, fed batch and continuous fermentation.Working within a diverse team with many different stakeholdersProficient in aseptic techniques (BSL2) for cell growth of primary cell lines. Good to have Skills: Previous working knowledge on cell culture and bioprocess engineering is a plus.  Educational qualification: PhD. in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology or Microbiology, Bioprocess development, Biotechnology or related field with 2+ years or M.Sc. with 4+ years of relevant industrial hands-on experience

Responsibilities:The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.Communicates to multiple departments and supervision to provide timely process and issue updates.Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.Participates in reviews and structured processes for continuous improvement.  Quality Operations:Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substances.Performs GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databases.Collects retain samples and performs sample evaluation for Annual Product Review.May backup third party product review/release.Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.Non-conforming events:Responds to and escalates events identified during production to Quality Management.Participates in investigations with the Rapid Response Team as needed.Process Improvement:Collaborates with Manufacturing and Quality partners to identify and implement improvements.Compliance:Conducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BR requirements.Actively participates in training events, and maintains currency with assigned training requirements.Safety:Follows all procedures to ensure a safe and compliant work environment.Requirements:Education & Experience:High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Ability to communicate and work with teams.Attention to detail.Strong documentation skills.Ability to read and interpret SOPs and function within the scope of procedures.

Responsibilities:Apply specialized scientific knowledge in creative ways to develop new innovative pharmaceutical products/processes. Independently plan, execute and manage projects, incorporating advanced theories, methods and technologies in multiple disciplines to generate innovative solutions to complex problems where little clear precedence exists.Leverage input from colleagues in R&D and other functions e.g. Commercial, Clinical, Legal, and Manufacturing to create innovative products/processes/methods through novel combinations of expertise within the organization. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them to increase product/process acceptance, quality and reliability.Identify opportunities for our intellectual property and work with Legal counsel to file patents. Present research results at external conferences and publish articles in peer-reviewed scientific journals as appropriate. Supervise and direct the laboratory work for a small team of lower level formulation and analytical scientists to facilitate rapid assessment of novel product formulation concepts, leveraging right first time/fail fast approach to evaluate and recommend promising product candidates to enter our product development process.Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, supervisor and technical advisor to junior members within the discipline.Requirements:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Must possess strong knowledge of pharmaceutical formulation science and solid knowledge of related disciplines, plus knowledge of quality and general business systems.Possess an in-depth knowledge and understanding of GxP and related regulations and guidance, and ability to leverage for efficient product designMust possess strong ability to negotiate for resources and influence others internally and externally.Must be able to challenge the status quo.Must be able to contribute in setting strategic scientific direction for the organization and communicate the vision to his/her team members. Can comfortably handle risk and uncertainty; can decide and act without having the total picture.Education and/or Experience:Include the education and/or experience that is necessary to perform the job satisfactorily.Bachelor's degree in a scientific discipline with at least 15 years of relevant experience, MS with at least 10 years, or PhD with at least 3-4 years of relevant experience. QSR research experience is essential and GMP experience useful.Lab experience includes research and/or development in GMP/QSR environment, leadership of technical teams, and technical leadership of drug product development programs. Project management experience is desirable.

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

Skills

Industry

Location

Jobtitle

5 gmp Jobs found

MSAT Engineer

MSAT Executive

Associate I, Quality Operations

Innovation Lead/ Research Scientist II

QC Chemist I

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

5 gmp Jobs found

MSAT Engineer

MSAT Executive

Associate I, Quality Operations

Innovation Lead/ Research Scientist II

QC Chemist I

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.