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INDEX JOB OPENINGS CONTACT US CANDIDATE REFERRAL

 

Quality Engineer  #20893

 

Our client company is developing delivery methods for a proprietary drug formulation – Delivery methods will address patient usage for both the in-patient and at home care situations and will be used in helping treat a variety of disorders.  The Quality Engineer will work with new product development team for verification and validation of design outputs.

 

Responsibilities:

Provide support for new/revised product development projects:

§        Serve as quality engineer on new /revised development projects as assigned.

§        Participate in the new product development creation of complete, unambiguous, and measurable design inputs

§        Work with new product development team for verification and validation of design outputs.

§        Review component selections and verification, tooling validations, product designs, testing protocols and co-development of critical characteristics/tolerances for initial testing and subsequent routine manufacturing controls.

§        Assist in development specifications for new/revised products and components.

§        Assist in compilation of data in support of Management Reviews. 

§        Support risk assessment activities: FMEA/FTA, etc.

§        Author and assist in the execution of test protocols in support of design and product verification and validation efforts.

§        Support the development of complete and compliant Design History Files, Device Master Records, and respective labeling for safe and effective products.

§        Support supplier quality program, including evaluation, selection, and qualification.

§        IQ, OQ, and PQ qualifications and validations.

§        Identify applicable standards for inclusion in new product development specifications.

§        Assist in creation of procedures as assigned.

   Qualifications:

§        Bachelor’ s degree in engineering, sciences, or related field.

§        Certification in Quality Engineering a plus.

§        3 to 7 years relevant design control activities and risk management experience within an FDA regulated industry.

§        Strong working knowledge and understanding of 21 CFR 820.30 and ISO 14971.

§        New product development experience is required.

§        Proficient with Microsoft Office applications.

§        Excellent written and verbal communication skills.

 

Must have the necessary legal/visa status to work at a for-profit company in the US.

 

Keywords: Quality, Engineer, CFR, Verification, Validation, FDA-regulated,   Design Control, Risk Management, FMEA, FTA   .

                     IQ, OQ, PQ

 

Location:  US East coast.

 

 

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Project Manager, Drug Development  #20891

Our New Jersey (USA) biotech client is focused on breakthrough CNS research and clinical trials.  The Project Manager will participate in numerous product development projects from pre-clinical safety through regulatory approval.  This candidate will interact with senior management and report to the Vice President of Development.  S/He will support new product planning and identify and implement improvements that optimize product development processes. 

 

  • The candidate must have a broad knowledge of biopharmaceutical drug development. 
  • Advanced degree and CBER experience are preferred.
  • Experience can include Clinical, Manufacturing and/or Regulatory Affairs.

 

Length of contract will depend on needs and expertise. This position may transition in to a full time position.

 

Must have the necessary legal/visa status to work at a for-profit company in the US

 

Keywords:  Drug Development,  Project Management

 

Location: New Jersey (USA)

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QA Director: cGMP Pharmaceutical  #2083

Leading pharmaceutical manufacturer is seek a Quality Assurance Director to manage 2-3 direct and 15 indirect reports.  The Director QA is the site liaison with the FDA and is responsible for coordinating site regulatory agency inspections  S/He will be accessible across the entire plant.

Duties/Responsibilities:

  • This position will be responsible for auditing of all production operations for compliance with current Good Manufacturing Practices, maintenance of Quality Systems, Deviations, CAPA, Documentation, Change Control, Self Inspection, Supplier Quality, etc.
  • Will also be providing guidance and regulatory feedback to the facility to insure compliance.
  • Responsible for department budget preparation and administration;
  • Provide on-going GMP training to the facility, set direction for department and site (in conjunction with Operations management).

  • Will provide environmental monitoring for facility, and any other activities deemed essential to maintenance of a compliant cGMP facility.

Candidate Qualifications:

  • Education:  BS or MS.
  • Experience:  A minimum of 6 yrs experience in cGMP Pharma industry.
  •  Solid Dose background required -  Liquid dose experience is a definite plus.
  • Strong Compliance background.
  • Strong leadership skills.

 

Must have the necessary legal/visa status to work at a for-profit company in the US

 

Keywords: Quality Assurance, Quality Systems, FDA,  CAPA, Deviations, Solid Dose. Change Control, Supplier Quality,  cGMP Training

 

Location:  US West coast.

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20892

QA Compliance Trainer    #20892

 

Leading pharmaceutical manufacturer is seek a Quality Assurance Director to manage 2-3 direct and 15 indirect reports.  The Director QA is the site liaison with the FDA and is responsible for coordinating site regulatory agency inspections  S/He will be accessible across the entire plant.

 

Major Duties and Responsibilities (including supervising others):

  • This position will be responsible for auditing of all production operations for compliance with current Good Manufacturing Practices, maintenance of Quality Systems , Deviations, CAPA, Documentation, Change Control, Self Inspection, Supplier Quality, etc.
  • Will also be providing guidance and regulatory feedback to the facility to insure compliance.
  • Responsible for department budget preparation and administration.
  • Provide on-going GMP training to the facility, set direction for department and site (in conjunction with Operations management).
  • Will provide environmental monitoring for facility, and any other activities deemed essential to maintenance of a compliant cGMP facility.

Qualifications:

  • BS or MS with a minimum of 6 yrs experience in cGMP Pharma industry.
  • Solid Dose background required - Liquid dose experience is a definite plus.
  • Strong Compliance background.
  • Strong leadership skills

   Must have the necessary legal/visa status to work at a for-profit company in the US.

 

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Protein Scientist, PhD:  Purification Development, Scale-up & Transfer  #2084

Our International biotech client is adding to their Development staff. The Protein Chemist will need strong protein purification skills, and will be responsible for the reduction to practice of purification protocols and scale-up methods. S/He will prepare documents that will aid

in transferring the scaled method to the cGMP facility.

  

Candidate Qualifications:

  • PhD in Protein Biochemistry, Biochem Engineering or related degree.
  • Very strong background in (recombinant) Protein purification protocols.
  • Expertise in column chromatography for purification purposes.
  • Expertise in protein purification development, scale-up and optimization from laboratory scale to pilot scale.
  • Competitive candidates will have lab management skills, including supervision of lab staff.

   Must have the necessary legal/visa status to work at a for-profit company in the US.

 

 Location:  US East coast

 

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Sr Scientist, Solid Formulations - Physical Chemistry  #2081

The primary objective of this role is to identify and investigate crystalline forms of compounds, conduct solid form characterization in early development, design and develop crystallization processes for drug substance, and ensure selection of the most appropriate solid form for development compounds.

 

Major Duties and Responsibilities:

  • Conducting salt selection and polymorph screening studies for development compounds.

  •  Characterization of physical properties of compounds using analytical tools such as XRD, DSC, TGA, Raman etc.

  • Addressing development challenges for drug substance and drug product related to solid form properties.

  • Maintaining and operating laboratory equipment and analytical instrumentation in the Solid Forms laboratory.

  • Design and execution of experimental programs to develop, optimize and scale-up crystallization processes for drug substance.

  • Co-ordinating with other groups within the company to ensure timely availability of Clinical Trial Materials.

  • Representing the group and provide technical expertise in cross-functional project team.

  • Providing technical input for regulatory filings, partnership due diligence etc.

 

Candidate Qualifications:

  • PhD in Physical Chemistry, Chemical Engineering, Chemistry or related fields.

  • 5+ years experience in the pharmaceutical industry working with small molecule new chemical entities (NCEs).

  • Knowledge of crystal structures, polymorphism, phase transformations, amorphous compounds, and physical properties    including the application of analytical tools (e.g. XRD, HPLC, IR, Raman, particle size).

  • Expertise in crystallization development, scale-up and optimization from laboratory scale to pilot scale.

  • Experience in recommendation of solid forms for development based upon bioavailability, manufacturing complexity and solid-state attributes.

  • Experience applying statistical approaches in the design and analysis of experiments.

  • Familiarity with oral solid dosage forms is a plus.

  • Extensive understanding of other disciplines related to solid forms development.

  • Thorough understanding and training in GMPs and regulatory requirements, experience with INDs is a plus.

   Must have the necessary legal/visa status to work at a for-profit company in the US.

Location:  US West coast

 

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Sr Scientist - Mass Spec -  Analytical Biochemistry Development  #2087

 

This Scientist opening will provide bio-analytical support for Research and Development. The responsibilities include, but not limited to, protein structure characterization and proteomics applications. The successful candidate will conduct experiments using mass spectrometry (MS) and chromatography techniques for the structural characterization of biopharmaceutical products, such as humanized monoclonal antibodies and recombinant proteins.

Position Requirements:

Special Skills/Abilities:

  • Strong expertise and hands-on experience on every aspect of protein structure characterization and proteomics, i.e., mass spectrometry, chromatography, and protein chemistry.
  • Mass spectrometry (MS) and chromatography techniques for the structural characterization of biopharmaceutical products, such as humanized monoclonal antibodies and recombinant proteins.
  • Demonstrable expertise in performance of MS experiments and interpretation of the data to characterize and identify post-translational modifications of proteins, such as deamidation, oxidation, and glycosylation.
  • Understanding of cell biology and immunology is a plus.

Education and Experience:

  • Education:  Ph.D. or M.S. in BioChemistry, Analytical Biochemistry, Protein Biochemistry, BioEngineering or, Biological Sciences. 
  • Experience: Ph.D. with 3 or more years of relevant experience, or M.S. degree with 8 or more years relevant experience.  Industrial bio-analytical experience is preferred.
  • Thorough understanding of structure characterization of proteins by mass spectrometry and chromatography is necessary.
  • Strong experience in ESI LC-MS, especially QTOF (Waters) and Ion trap (Thermo) types of instruments and HPLCs (Agilent and Waters) is required.
  • Solid experience in working with recombinant proteins and ideally, Monoclonal Antibodies.
  • Must have experience with CMC (Chemistry, Manufacturing & Controls Documentation).
  • Familiarity with SOP and GLP requirements in biopharmaceutical product development.

Must have the necessary legal/visa status to work at a for-profit company in the US.

 

Keywords: Mass Spec/Mass Spectrometry, LCMS, LC/MS, LC-MS; (nano LCMS), Proteomics, Deamidation, Glycosylation,      Chromatography, ESI LC-MS/Electrospray ionization LC MS, Post-translational changes.

                     Recombinant proteins, Therapeutic proteins, Monoclonal Antibodies

 

Location:  US East coast.

 

 

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Pharmaceutical Manufacturing Manager:    #2076

Our client company is a rapidly growing biotechnology company that offers a stimulating, challenging and productive environment.  We are seeking a highly motivated and energetic individual for a Pharmaceutical Manufacturing Manager position within the Process R&D and Manufacturing group.

Duties/Responsibilities:

§        Conducting technology transfer and oversight of drug product manufacturing at a contract manufacturing organization.

§        Tracking progress of outsourced activities and schedules for drug supplies produced at our contract manufacturing organizations.

§        Managing Clinical Trial Materials inventory, storage and distribution in support of clinical trials and R&D needs.

§        Maintaining inventory database, systems and documentation related to material receipt, storage and distribution in compliance with regulatory requirements.

 

Candidate Qualifications:

§        Education:  BS/MS/PhD in Pharm Sci/Engineering or related field..

§        Experience:  BS/MS with 5 - 8 yrs in Pharma industry;  PhD with 4 - 5 yrs in Pharma industry.

§        Experienced in the manufacture of drug products under cGMP.

Must have the necessary legal/visa status to accept an offer of work in the US.

Location:  US West coast.

 

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