Jobs in Pharmaceutical
Microbiologist 2
Title: Microbiologist
Location: Malvern, PA
Duration: 12 Months+
Description:
Performs qualitative and quantitative chemical/microbial analysis of in-process manufacturing materials. Coordinates testing responsibilities to ensure QA test support according to the needs of Manufacturing to maintain continuous process flow. Functions as a team member in the QA Microbiological Laboratories to provide timely test analysis information on the status of conformance to requirements. Investigates testing abnormalities and implements corrective action. Cross-trains in all testing responsibilities to ensure a fully cross-functional laboratory team environment. Assists with determination of root causes of non-conformances and recommends corrective actions. Maintains laboratory chemical supplies to ensure an adequate supply and prevent testing delays. Audits documentation, device history records, and test methods for compliance. Assists with special projects by supporting the development of new test methods of performing investigative test analyses as required. Cross-trains in all testing responsibilities to ensure a fully cross-functional laboratory team environment. Audits documentation, device history records, and test methods for compliance. This position will be Sunday-Thursday 1st shift including occasional holidays.
Bachelor’s degree required.
Pharmacokinetic Scientist 5
- Provide small and large molecule clinical pharmacology expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).
- Performs pharmacokinetic analysis, interpretation, and reporting of data from clinical studies. o Responsible for design, analysis and communication of data on clinical pharmacology studies.
- Develops and implements new clinical pharmacology studies that impact development programs.
- Effectively represents clinical pharmacology in cross-functional study-team settings.
- Works in close partnership with Quantitative Pharmacology, Bioanalytical Chemistry, Project Management, Clinical Research, Biostatistics and Clinical Trials Management functional areas to support clinical development programs. Conducts clinical pharmacology studies in line with clinical PK and product development strategies.
- Designs and works with CRA regarding implementation and conduct of clinical pharmacology studies.
- Analyzes, interprets, and writes reports for clinical and regulatory submissions. Ensures the quality of patient care and adherence to scientific, safety and regulatory standards.
- Assists with managing timelines and budgets to insure prompt and accurate execution of clinical studies.
- Analyzes moderately complex problems in component parts and to identify causal relations.
- Contributes to and represents department on multifunctional project teams.
- Excellent verbal, written, and interpersonal communication skills and ability to convey moderately complex technical information clearly to others are required.
- In-depth knowledge and understanding of pharmacokinetic regulatory requirements for US and EC are required. Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, SAS etc.) along with PK modeling and computer skills in scientific graphing.
- PharmD, PhD, with pharmacokinetic training, fellowship and/or postdoctoral experience and 2+ years of clinical pharmacology/pharmacokinetics. o Strong understanding of clinical pharmacokinetic concepts is required. Training/experience in advanced pharmacokinetics, clinical pharmacology and/or pharmacy with clinical research, drug development is desirable.
- Understanding of drug development process to provide clinical pharmacology support for clinical development (Phase 1 to Phase 4) for investigational agents and/or marketed drugs.
- Hands-on experience in clinical trials management/study conduct and/or basic laboratory sciences is desirable.
- Must have established computer skills with detailed knowledge of PK programs and analysis software (e.g. WinNonlin), along with experience with scientific graphing and analysis software (Sigma plot, GraphPad, Instat, etc). Must have excellent written and verbal communication skills.
- Must have excellent interpersonal, written and verbal communication skills.
- Must have critical thinking skills and ability to make decisions
- Demonstrate ability to work independently o Exhibit excellent written and verbal data presentation skills to enable contribution to internal/external teams, conference presentations and publications
Chemist I 5
Description:
The ChemistI conducts analytical testing of stability samples submitted to the QC laboratories according to testing schedules in a productive and efficient manner. This position requires testing to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)
Additional tasks, duties, and responsibilities include utilizing electronic systems (LIMS, Empower, etc.) for execution and documentation of testing, sample and reference standard management, maintaining individual training completion in a compliant state, completing corrective and preventative actions (CAPA) as assigned, supporting the investigation and resolution of laboratory non conformances, general housekeeping and other duties as assigned by management.
Education & Experience:
This role requires a minimum of a B.S. degree in a scientific field and a minimum of 12 years experience working in a GMP laboratory environment.
Required skills, knowledge and ability for this role include
knowledge and experience with analytical technologies used in a QC Laboratory (HPLC, FTIR, dissolution, UV/Vis, etc.)
knowledge and understanding of current Good Manufacturing Practices (cGMP)
Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
Basic troubleshooting and root cause analysis skills
TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.
Chemist 6
Title: Chemist
Location: TITUSVILLE, NJ
Duration: 12 Months+
Description:
The Chemist-I conducts analytical testing of stability samples submitted to the QC laboratories according to testing schedules in a productive and efficient manner.
This position requires testing to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)
Additional tasks, duties, and responsibilities include utilizing electronic systems (LIMS, Empower, etc.) for execution and documentation of testing, sample and reference standard management, maintaining individual training completion in a compliant state, completing corrective and preventative actions (CAPA) as assigned, supporting the investigation and resolution of laboratory nonconformances, general housekeeping and other duties as assigned by management.
This role requires a minimum of a B.S. degree in a scientific field and a minimum of 1-2 years’ experience working in a GMP laboratory environment.
Required skills, knowledge and ability for this role include;
-knowledge and experience with analytical technologies used in a QC Laboratory (HPLC, FT-IR, dissolution, UV/Vis, etc.)
-knowledge and understanding of current Good Manufacturing Practices (cGMP)
-Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
-Basic troubleshooting and root cause analysis skills.
Scientific Support 5
Job Title: Scientific Support
Duration: 6 Months
Location: ASHLAND, OH
Responsibilities
- Provides administrative, logistical and technical support for Scientific staff conducting studies or supporting functions for operations of the laboratory.
- Coordinates all laboratory support, pre-study activities, method development, method validation, study activities, data and/or reporting activities.
- Responsible for data review for completeness, quality or QC against the applicable protocol or procedure.
- May be responsible for drafting client correspondence, study correspondence, reporting or direct client interaction.
- Interacts with other departments, scientific staff, and sponsors either locally or across sites.
Quality Control Research Associate 16
Job Title : Quality Control Research Associate
Duration : 6 Months (Possibility of extension)
Location : Gaithersburg, MD
Job Responsibilities::
- Conducts routine analyses based on written procedures
- Reviews data and results of testing to ensure compliance to appropriate specifications and protocols.
- Performs maintenance and calibration of analytical instrumentation.
- Begins to learn and apply knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) on a daily basis.
- Writes simple protocols and reports.
- Must have working knowledge of Microsoft Office software.
- Participates in group meetings.
- May present data or prepare information for others to present.
Manufacturing Associate 27
Job Title : Manufacturing Associate
Duration : 12 Months (possibility of extension)
Location : Chaska, MN
Essential Duties/Responsibilities:
- Assemble various types of electro-Mechanical sub-assemblies.
- Assemble cables, Tubes, and wiring harnessing.
- Following all assemblies documented procedure.
- Follow company DHR, GMP, SOP, QSR, and adhere to company quality procedures and policy.
- Train on latest revision of procedures and work instructions as well as update on training for best performance on quality products.
- Follow Company Safety Policy.
- Have good understanding and be knowledgeable on Good Manufacturing Practice.
- Maintain a Clean and Organized work area.
- Good Hand Dexterity.
- Complete all inventory transactions and assemble packaging.
Requirements:
- High School Diploma, Requires a minimum of one year current electro-mechanical assembly experience.
- Read assembly drawings, bill of material, follow assembly instructions and schematics written in English.
- Operate various types of hand tools.
- Experience in QSR or ISO environment
Clinical Pharmacologist 32
- Leading complex clinical pharmacology studies
- Providing leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1-4 clinical development for development compounds in your therapeutic area(s)
- Representing the department and providing subject matter expertise on cross-functional project teams
- Developing and maintaining collaborative working relationship with colleagues within and outside the department
- Mentoring junior level scientists, including direct reports or supporting team members
- Authoring/ and reviewing clinical protocols, analysis plans, study reports and regulatory submissions
- Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
- Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Participating in and collaborating with individuals from across the business in special projects
- Developing and presenting training within and outside the department
- 8 to 10 years’ experience and a, PhD, PharmD or MD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline
- In-depth knowledge of pharmacokinetic and other analysis software programs (eg. WinNonlin, GraphPad, etc.)
- Knowledge of current and emerging scientific standards regulatory requirements
- Excellent written and oral communication skills and ability to convey complex technical information clearly
- Ability to critically analyze problems and provide creative solutions
- Confidence and discipline to work autonomously
- Genuine curiosity and drive to ask questions – looking for the ‘why’ of every project
- Desire to strive for continuous improvement
Manufacturing Operator 24
Job Title: Manufacturing Operator
Work Location: Haverhill MA
Duration: 6+ months (possible extension)
- High School Diploma / GED.
- 2+ years' experience in an industrial setting with thorough knowledge of safety procedures relating to chemical handling.
- 1+ year experience or skill in SAP or similar software such as ERP or MRP systems.
- Performs production procedures in accordance with Standard Operating Procedures (SOP), resulting in quality product.
- Formulation Tasks: Gather chemicals from different storage locations (i.e. room temperature, coolers and freezers); use designated weights from 1 gm to 250 kg to verify scales; scoop and dump chemicals into containers up to 1,000 kg; place finished containers on a scale to verify gross weights; use a computer to capture production information; approve related reports and complete related documentation.
- Equipment components can weigh up to 50 kg and have critical tolerance requirements.
- Report equipment failures and work with repair personnel to correct problems
- Performs procedures resulting in the cleaning of manufacturing equipment and facilities.
- Continually increases proficiency and understanding of manufacturing processes and systems.
- Able to Read and understand all written procedures as outlined in SOPs, Work Instructions and Master Batch Records (MBR).
- Completes all documentation in accordance with current Good Manufacturing Practices (cGMP) and SOP.
- Maintain good housekeeping in working areas.
- Reports any unsafe working conditions or safety concerns through the corporate Medgate system.
- Reports any property damage to the shift supervisor immediately
- Takes part in and contributes to a safe working environment by following corporate and departmental safety regulations. Use, clean, and store all personal protective gear appropriately
- Makes recommendations for continuous process improvements in the manufacturing area.
- Actively participates in Quality systems practices.
Education
- High school diploma or equivalent with good math and reading skills.
- Experience in a manufacturing environment preferably with cGMP or regulatory compliance practices. Demonstrated mechanical aptitude including previous maintenance experience with process equipment or mechanical systems. Dry product processing and packaging experience.
- Ability to read and follow written and verbal instructions.
- Ability to perform basic metric and other mathematical calculations.
- Ability to work independently and as part of a team.
Lab Tech 26
Job Title: Lab Tech
Location: La Verne, CA 91750
Duration: 3 Months (Contract with high possible extension)
Job Description:
Environmental Monitoring Tech (EM Tech):
- **Minimal lab and bench work.
- The majority of the work is field
- Shift will vary and the candidate is asked to work with a flexible schedule.
- This is a labor intensive job that entails having to gown (various degrees) to enter classified manufacturing areas, having to stand on feet for 2+ hours, pushing carts, carrying 5 lbs.
- Prefer someone with EM experience and/or who has some experience and/or knowledge of aseptic manufacturing operations.
Job duties would include:
- Sampling water, sampling compressed gases, autoclaving laboratory supplies and other general laboratory maintenance duties.
- This person will have to gown up to go into some of the manufacturing areas.
- Depending on skill set, they may also be trained to perform environmental monitoring (surface monitoring, viable air and non-viable particles).
- Will perform record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
- Prior experience in biopharmaceutical or pharmaceutical industry preferred.
Prior EM or lab experience preferred.
EM = Environmental Monitoring - Monitoring of classified manufacturing areas for surfaces, viable air and non-viable particulates
Critical Utilities - Sampling of reverse osmosis water, water for injection, pure steam and compressed gases