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Manager or Director, Business Development (Job Code: BD)

This is a work from home opportunity with some overnight travel required. The position will be based In Boston and San Diego Area. You will be responsible to identify and secure new business as well as assist in maintaining an existing client base. Responsibilities include but not limited to:

  • Proactively analyze market, implement sales tactics and achieve pipeline/sales target
  • Identify and realize business opportunities in responsible territory/accounts
  • Maintain and extend relationship with existing clients by guarantee clients’ satisfaction and address their needs timely
  • Monitor market trends, competitive landscape and clients’ feedback; periodically report the information to senior management and related teams
  • Generate publicity and influence of the company through networking, professional conferences and trade shows

Skills Required and/or Desired
Exceptional communication (both written and verbal) are required and analytical skills are desired for this position.

  • Pharmaceutical industries experience especially business development for contract laboratory required: 2 or 5 years of contract lab business development experience highly desired for manager or director position respectively
  • Proven track record working with pharmaceutical companies both innovator and generic
  • An ability to prospect for new relationships and secure new business
  • An ability to work in a collaborative manner with laboratory operations/business units
Apply Here

Director, Formulation Development (Job Code: FD)

  • Lead drug product formulation development for generics as well as innovative
  • Lead all aspects of formulation development team at Primera including staff hiring and development, daily operation and compliance, budget and expense tracking, regulatory strategy, submission management and client interaction as well as team development
  • Provide scientific and related regulatory expertise regarding formulation development ranging from generics reformulation, preclinical to clinical research phase as well as other late-phase formulation development NDA/ANDA/505b(2) to seek regulatory approval
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Interact closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements
  • Write and review relevant reports for ANDA/IND/NDA applications
  • Support business expansion with existing customers and broaden the customer basis by participating strategy development and business development activities (with respective business units)

Requirements:

  • PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years’ experience in pharmaceutical industries
  • 3+ year experience in leading generics reformulation especially modified/extended release dosage forms with demonstrated successful ANDA or 505b(2) filing
  • Innovative small molecule formulation development with demonstrated successful IND or NDA application filing highly desirable
  • Excellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills
  • Good knowledge of cGMPs, ICH guidelines, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, EMA/FDA CMC guidance documents will be an advantage
  • Ability to work in a fast-paced, dynamic, environment
Apply Here

Senior Scientist – BioAnalytical Development

  • Lead drug product formulation development for generics as well as innovative
  • Lead all aspects of formulation development team at Primera including staff hiring and development, daily operation and compliance, budget and expense tracking, regulatory strategy, submission management and client interaction as well as team development
  • Provide scientific and related regulatory expertise regarding formulation development ranging from generics reformulation, preclinical to clinical research phase as well as other late-phase formulation development NDA/ANDA/505b(2) to seek regulatory approval
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Interact closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements
  • Write and review relevant reports for ANDA/IND/NDA applications
  • Support business expansion with existing customers and broaden the customer basis by participating strategy development and business development activities (with respective business units)

Requirements:

  • PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years’ experience in pharmaceutical industries
  • 3+ year experience in leading generics reformulation especially modified/extended release dosage forms with demonstrated successful ANDA or 505b(2) filing
  • Innovative small molecule formulation development with demonstrated successful IND or NDA application filing highly desirable
  • Excellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills
  • Good knowledge of cGMPs, ICH guidelines, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, EMA/FDA CMC guidance documents will be an advantage
  • Ability to work in a fast-paced, dynamic, environment
Apply Here

Director, Formulation Development

This is a work from home opportunity with some overnight travel required. The position will be based In Boston and San Diego Area. You will be responsible to identify and secure new business as well as assist in maintaining an existing client base. Responsibilities include but not limited to:

  • Proactively analyze market, implement sales tactics and achieve pipeline/sales target
  • Identify and realize business opportunities in responsible territory/accounts
  • Maintain and extend relationship with existing clients by guarantee clients’ satisfaction and address their needs timely
  • Monitor market trends, competitive landscape and clients’ feedback; periodically report the information to senior management and related teams
  • Generate publicity and influence of the company through networking, professional conferences and trade shows

Skills Required and/or Desired
Exceptional communication (both written and verbal) are required and analytical skills are desired for this position.

  • Pharmaceutical industries experience especially business development for contract laboratory required: 2 or 5 years of contract lab business development experience highly desired for manager or director position respectively
  • Proven track record working with pharmaceutical companies both innovator and generic
  • An ability to prospect for new relationships and secure new business
  • An ability to work in a collaborative manner with laboratory operations/business units
Apply Here

Senior Scientist – BioAnalytical Development

Work Site: Cranbury, NJ
Duties and Responsibilities

  • Conduct routine and non-routine analyses of test articles using biochemical methods including HPLC, LC-MS/MS, GC and USP dissolutions.
  • Perform routine and non-routine analytical testing using Ligand Binding assay.
  • Perform bioanalytical method development and validation for PK and ADA.
  • Operate plate reader for method development, method validation and sample analysis.
  • Responsible for sample coordination, lab equipment maintenance, document management, inventory control and sample requests/documents reconciliation.
  • Use scientific expertise to assist in troubleshooting, laboratory investigations and problem resolution.
  • Compile data and prepare graphs for documenting test procedures and reports.
  • Conduct document reviews, author Standard Operating Procedures (SOPs), and assay review.
  • Conduct special projects including method validation, troubleshooting, optimization and investigations.
  • Apply cGMP/GLP practices during execution of all work tasks.
  • Update supervisor and clients the working progress at scheduled intervals.

Qualifications:

  • Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Engineering or related field.
  • 1 year of experience in cGMP/GLP and FDA guidelines; and analytical methods including HPLC, GC, LC-MS, USP Dissolution.
  • Demonstrated ability to apply and implement GMP regulations into day to day tasks.
Apply Here

Scientist /Associate Scientist – Biologic Analytical Development (Job Code: BIO)

Job Description
The Associate Scientist/Scientist – Biologic Analytical Development is responsible for the development and qualification of assays for biologic products.
Duties and Responsibilities

  • Participate assay development and optimization for ELISA, flow cytometry, bioassay, PCR and CE for biologic materials.
  • Prepare methods for the transition to a GMP QC environment
  • Author method procedures and SOPs
  • Maintain sample and data integrity at all times
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.
  • Perform equipment maintenance and calibrations as required.
  • Maintain lab readiness for audits by both internal and external authorities.
  • Execute qualification/validation of analytical methods per ICH & USP guidelines
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • BS or MS in a science related field, including but not limited to Chemistry, Pharmacology, food science, Chemical Engineering, Biology and Healthcare.
  • 4-6 years of experience in a biologics laboratory with a BS or Master’s Degree and 2-4 years of related experience or Ph.D. and 2 years of related experience
  • Knowledge of most laboratory equipment including but not limited to plate readers, cytometer, PCR & CE
  • Experience in developing assays for a biological product
  • Written communication skills require full competence in following detailed written instructions, creating/revising SOPs, protocols and reports
  • Knowledge of chemical and biological safety procedures/precautions
  • Proficient in Microsoft Office – Outlook, Word, Excel, Powerpoint
Apply Here

Scientist/Associate Scientist – Analytical Development (Job Code: ANA)

Summary of the JobValidation and routine execution of a range of in vitro ADME assays including permeability, metabolic stability, tissue/protein binding, solubility, drug-drug interaction, and in vivo PK studies, including study design, sample preparation, sample analysis using LC-MS/MS, and data report to support drug discovery and development for clients. Implementation of new technologies/sciences within the areas of expertise to improve the data quality of the studies in screen and selection of drug candidates.
Duties and Responsibilities

  • Comply with all the Standard Operating Procedures applicable to the job tasks.
  • Conduct assays and sample preparations following established procedures to support drug discovery programs of the clients.
  • Operate LC-MS for compound tuning, method development, and sample analysis.
  • Assist development of new assays to help improve service capabilities.
  • Assist troubleshooting of the issues/problems arisen from the assays and execute solutions for problem solving.
  • Maintain detailed records and notebooks to assist method/report writing and data interpretation.
  • Train other scientists in running established assays.
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals.

Qualifications:

  • PhD in Biology, Chemistry or related discipline with greater than 2 years, Master’s Degree with greater than 5 years, or Bachelor’s Degree with greater than 8 years’ experience in a laboratory environment
  • Expertise in advanced experimental methods including cell culturing skills as well as the concepts and techniques relevant to scientific discipline.
  • Scientific/technical independence and creativity.
  • Ability to expand knowledge in the relevant scientific discipline through related scientific literature.
  • Ability to conduct researches collaboratively and propose methodologies for projects.
  • Attention to detail and awareness of potential impact from any concerns.
  • Good at written communication and oral presentation
Apply Here

Scientist – Bionalytical (Job Code: BA)

Duties and Responsibilities

  • Perform routine and non-routine analytical testing using variety of analytical techniques such as: LC-MS/MS, HPLC, GC, etc.
  • Perform bioanalytical method development and validation independently with minimum supervision.
  • Operate LC-MS for compound tuning, method development, and sample analysis.
  • Demonstrate initiative to perform routine laboratory responsibilities such as sample coordination, lab equipment maintenance, document management, inventory control, and reconciliation of sample requests/documents as needed.
  • Following cGMP/GLP regulations when executing his/her daily work load.
  • Update supervisor his/her work progress at scheduled intervals.
  • Apply his/her scientific expertise for analytical methods/instruments troubleshooting, laboratory investigations, etc.
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals.

  • Qualifications:

  • BS or MS (preferred) in a related science such as Chemistry or Pharmacology.
  • BS requires 1-5 years and a MS requires 0-3 years of previous related experience
  • Basic working knowledge of cGMP/GLP regulations is required.
  • Ability to work independently and achieve problem resolution with minimal supervision. Attentive to detail.
  • Excellent teamwork and communication skills.
  • Good computer skills, profound knowledge with Microsoft word, Excel, and PowerPoint.
Apply Here

BioAnalytical Scientist – Large Molecule (Job Code: BSLM)

Duties and Responsibilities

  • Perform routine and non-routine analytical testing using of analytical techniques such as: Ligand binding assay (ELISA, MSD) and Nab Assay for ADA
  • Perform bioanalytical method development and validation for PK and ADA.
  • Operate plate reader (Molecular device, MSD) for method development, method validation and sample analysis.
  • Demonstrate initiative to perform routine laboratory responsibilities such as sample coordination, lab equipment maintenance, document management, inventory control, and reconciliation of sample requests/documents as needed.
  • Following cGMP/GLP regulations when executing his/her daily work load.
  • Update supervisor his/her work progress at scheduled intervals.
  • Apply his/her scientific expertise for analytical methods/instruments troubleshooting, laboratory investigations, etc.
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • BS or MS (preferred) in a related science such as Biology or Pharmacology.
  • BS requires 1-5 years and a MS requires 0-3 years of previous related experience
  • Basic working knowledge of cGMP/GLP regulations is required.
  • Ability to work independently and achieve problem resolution with minimal supervision. Attentive to detail.
  • Excellent teamwork and communication skills.
  • Good computer skills, profound knowledge with Microsoft word, Excel, and PowerPoint.
Apply Here

QA Associate/Senior Associate – Quality Assurance (Job Code: QA)

Job Description
The QA Associate/Senior Associate is mainly responsible for performing and managing the audit of Analytical GMP and Bioanalytical GLP data packages from the laboratory.
Duties and Responsibilities

  • Performs periodic audits of data packages
  • Works with clients and managers to develop project QA plans
  • Helps to train other associates in QA
  • Prepares, manages, and maintains the training file documents
  • Assures adherence of acceptable GMP and GLP practices by the staff
  • Performs training within the group or throughout the organization as needed
  • Ensures timely completion of all quality plan objectives and milestones
  • Supports the on-time performance metric
  • Ensures compliance with applicable regulatory guidelines
  • Participates in regulatory and partner inspections as necessary.
  • Ensures timely follow-up to inspection findings

Qualifications:

  • 2-5 years of experience in the Analytical GMP and/or Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree
  • Previous technical experience in the areas of chemistry, biochemistry, or biology
  • Must possess a working knowledge of GMP/GLP requirements and other policies/regulations as applicable
  • Must possess a conceptual understanding of all Quality functions and business areas
  • Must have the ability to function in a fast-paced environment and communicate effectively with management.
Apply Here

QA Manager/Associate Director – Quality Assurance (Job Code: QA)

Job Description
The QA Manager/Associate Director is mainly responsible for managing the day-to-day activities related to Bioanalytical GLP QA activities.
Duties and Responsibilities

  • Manage and ensure all the activities related to Bioanalytical GLP QA activities are completed as required
  • Perform periodic audits of data packages
  • Review and approve protocols and reports for GxP studies with an emphasis on GLP studies
  • Ensure compliance with applicable regulatory guidelines
  • Evaluate studies in determination of root cause and assess quality impact
  • Recommend CAPA’s and follow-up to ensure CAPA’s implemented are effective.
  • Perform training throughout the organization as needed
  • Work with clients and senior management to develop QA project plans
  • Participate in regulatory and partner inspections as necessary. Ensure timely follow-up to inspections findings
  • Review non-conformance events, log books, procedures, and training as needed
  • Write SOPs, reports, and conduct document reviews
  • Implement process improvements with senior management
  • Use scientific expertise to provide assistance to co-workers and troubleshooting, laboratory investigations, and problem resolution

Qualifications:

  • Minimum of 5 years of experience in the Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree
  • Previous technical experience in the areas of chemistry, biochemistry, or biology
  • Must possess a working knowledge of GLP requirements and other policies/regulations as applicable
  • Must possess a conceptual understanding of all Quality functions and business areas
  • Must have the ability to function in a fast-paced environment and communicate effectively with senior management
Apply Here

Chemist (3 Openings)

Worksite: Cranbury, NJ
Duties and Responsibilities

  • Conduct routine/non-routine analyses on in-process materials, drug substances and finished goods
  • Design and perform method verification and validation
  • Develop analytical test procedure under manager’s direction
  • Prepare documentation of test procedures and technical reports
  • Apply scientific expertise to troubleshooting, laboratory investigation and problem resolution
  • Author standard operating procedures (SOPs) and conduct document reviews
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • Master’s degree in Chemistry/Chemical Engineering
Apply Here

Senior Scientist

Worksite: Cranbury, NJ
Duties and Responsibilities

  • Oversee and monitor laboratory workload of routine and non-routine analyses by appropriate chemical test methods such as HPLC, LC-MS, GC, USP Dissolution wet chemistry assays
  • Plan and organize analytical projects as per specifications and objectives
  • Ensure lab duties including sample coordination lab equipment maintenance, document management, inventory control and reconciliation of sample requests/documents are performed accurately by junior scientists. Supervise up to 5 junior scientists
  • Check compiled data and documentation of test results
  • Conduct documenta reviews including SOPs protocols and test reports
  • Apply cGMP/GLP during execution of all work tasks
  • Use scientific expertise and analytical skills in troubleshooting, laboratory investigations and problem resolutions
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Engineering or related field
  • One-year experience or training in cGMP/GLP and FDA guidelines; and Analytical methods including HPLC, GC, LC-MS, USP Dissolution
  • Demonstrated ability to apply and implement GMP regulations into day to day task
Apply Here

Analytical Scientist – Large Molecule

Duties and Responsibilities

  • Multiple openings
  • Perform routine analytical testing using analytical techniques such as: Ligand binding assay (ELISA, MSD), cell-based assay, flow cytometry, PCR
  • Perform Method development and validation
  • Following GMP/GLP regulations when executing his/her daily work load
  • Apply his/her scientific expertise for analytical methods/instruments troubleshooting, laboratory investigations, etc.
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • BS or MS in a related science such as Biology or Biochemistry
  • BS requires 2-3 years and MS requires 1-3 years of previous related experience
  • Working experience of GMP/GLP regulations is preferred. Good communication skills
Apply Here

Analytical Scientist – General Small Molecule and Large Molecule Analytical Techniques

Duties and Responsibilities

  • Multiple openings
  • Perform routine analytical testing using techniques such as: HPLC, GC, USP dissolutions, wet chemistry, etc.
  • Perform method development and validation following GMP regulations
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • BS or MS in a related science such as Chemistry or Pharmacology is required
  • BS requires 1-5 years and MS requires 0-3 years of previous related experience
  • Ability to work independently with minimal or moderate supervision. Excellent teamwork and communication skills. Attention to detail
Apply Here

Analytical Scientist – Organic Chemist

Duties and Responsibilities

  • Using organic chemistry knowledge, perform chemical structure characterization using NMR, LCMS and FTIR
  • You will be trained on operation of LCMS instrument after joining
  • Required to work in the laboratory that has a certain level of noise and contains hazardous chemicals

Qualifications:

  • MS in Organic Chemistry
  • Experience in organic synthesis is required
  • Ability to interpret 1H and 13C NMR spectra
Apply Here

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