MSAT Engineer

Associate I, Quality Operations

Specialist, DEA Compliance

QC Supervisor

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: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.

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

Responsibilities:Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing.Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.  Testing:Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.Perform methods development, transfer, verification and validation activities. Coordinate and assist with evaluation of Process Validations studies.   Documentation Practice, Training and Compliance:Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory.  Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.Lab Maintenance:Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.Monitor ordering of lab supplies.Enforce the control and management of controlled substances.  Staff Development: Evaluate potential candidates for QC; prepare annual performance evals. for chemists.   Prepare chemists and laboratory for FDA and other compliance audits.Ensures adequate resources are trained to support compliance and business initiatives.Requirements:Education & Experience:BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.7+ years of experience in pharmaceutical laboratory.2+ year QC supervisory experience preferred.Knowledge:Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.Skills & Abilities:Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.Good verbal and written communications with basic computer skills.Physical Requirements:Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment. Specific visions abilities are required by this job include close vision and color vision.The noise level in the work environment is usually moderate. The work environment is representative of a group laboratory environment. 

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 dea controlled substances Jobs found

MSAT Engineer

Associate I, Quality Operations

Specialist, DEA Compliance

QC Supervisor

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 dea controlled substances Jobs found

MSAT Engineer

Associate I, Quality Operations

Specialist, DEA Compliance

QC Supervisor

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.