Descriptions

"Search and Recruitment for BioPharma, Pharma,
Medical Diagnostics and Device Client Companies"

Mass Spec, Scientist - Sr Scientist:

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.

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.

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.

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 immediately work in the US.

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 immediately work in the US.

Location: US West coast

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