Director- Scientific & Business Operations

Position Overview

The Director of Scientific & Business Operations position and will be responsible for helping to supervise and mentor a team of Analytical Chemists in several aspects of department operations including reporting, method validation/qualification, investigating deviations, and unexpected results within R&D and GLP/cGMP environment. This person will serve as a liaison between our internal team and our Pharmaceutical clients.

We are seeking an experienced technical/scientific leader, who has in-depth knowledge and specific understanding of drug development for small molecules and biologics. This individual would provide strategic direction to the project teams and support Emery Pharma’s Analytical Chemistry Business Unit and Management. We are looking for a strong, entrepreneurial thinker, problem solver with an outstanding track record of building and leading scientific teams. You will be responsible for activities in support of our expanding pipeline of Client projects. This position will report directly to the CEO.

Essential Job Functions

  • Consults with clients on scientific needs, responds to RFPs, and establishes appropriate scope of work in collaboration with the Business Development team
  • Works in collaboration with Business Development team to outline scope of work, provide budgetary input, set project timelines, and anticipate technical challenges for each project
  • Participates in client meetings and preliminary discussions regarding client needs, provides technical knowledge to help outline project requirements and answer technical questions
  • Establishes the design and manages the conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements; i.e., GLP, GCP, ICH, etc.
  • Serves as a single point of contact for project directors and scientific team after project initiation
  • Organizes and communicates complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds
  • Reviews and approves reports, or reporting of results, within study timelines, and ensures any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate
  • Collaborating with the Chief Scientific Officer to support the growth and development of the department. Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities
  • Work interactively and cooperatively with all functions of the company and with senior staff to help achieve the company’s vision
  • Regular attendance and punctuality for all meetings and daily activities
  • May supervise team members within work group
  • These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Education and Requirements

  • Ph.D. or Master’s degree in chemistry is preferred, or equivalent combination of education and experience
  • 5-7 years of pharmaceutical industry experience
  • 3 years of progressive management responsibility or equivalent work experience
  • Strong Analytical background, as well as a knowledge of cGMPs, ICH, relevant FDA guidelines, and experience in writing relevant regulatory submissions
  • Experience in IND-enabling study design and management is preferred • Candidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next steps
  • Refine and enforce R&D and cGMP/GLP policies with emphasis on compliance to the company’s Quality Management System (QMS) and external regulatory standards including ISO-17025 and FDA regulations
  • Appropriate technical experience of relevant laboratory techniques within a regulated environment
  • Position is onsite full-time, Monday – Friday 9:00 am – 5:00 pm
  • Proficiency in hands on analytical work while managing internal and external activities
  • Exhibit strong technical skills and the ability to critically evaluate raw data and results without supervision
  • Must be skilled in operation of chromatographic data acquisition and processing software packages such as Agilent MassHunter, Thermo Scientific Chromeleon Chromatography Data System (CDS) software, Bruker TopSpin, Waters Empower ChromScope, and other software tools for data reduction and presentation
  • Experience with deposition, intellectual property and litigation-related projects a plus

Research Scientist – Analytical/Bioanalytical Chemistry

Position Overview

This is a Research Scientist position reporting to the Associate Director of Chemistry, for various research and development activities. This position will support a diverse set of projects and R&D activities of the company with a focus on analytical and bioanalytical chemistry, with exposure to quality management systems within a GLP/cGMP environment.

Essential Job Functions

  • Performing laboratory testing (method development and validation) to support Analytical Services workflow in accordance with Client deadlines/timelines.
  • Collaborate with the Business Development team and Senior Scientists to formulate project proposals and budgets for Clients, setting corporate and departmental goals and priorities.
  • Work closely with the chemistry team in terms of study initiation, data reporting and processing.
  • Ensuring analytical/bioanalytical equipment is maintained in good working order that includes
    troubleshooting and performing minor repairs, as needed.
  • Analytical chemistry with natural product experience, mass spectroscopy, and nuclear magnetic
    resonance (NMR) experience is a plus.
  • Work interactively with all functions of the company and with Senior Scientists to help achieve the company’s
    vision.
  • These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Education and Requirements

  • Master of Science (M.S.) in Analytical Chemistry or related scientific field
  • Minimum of 2-3 years of experience in R&D or equivalent lab environment
  • 2-3 years of hands-on experience with LC-MS, MS/MS assay development
  • Must be skilled in the operation of chromatographic data acquisition and processing software packages
    such as Agilent MassHunter, Thermo Scientific Chromeleon Chromatography Data System (CDS) software, Bruker TopSpin, Waters Empower ChromScope, and other software tools for data reduction and presentation
  • Candidates with a strong understanding of bioanalytical procedures strongly preferred
  • Exhibit strong technical skills and the ability to critically evaluate raw data and results without
    supervision
  • Prior work experience in GLP/cGMP environment and working knowledge of NMR is a plus
  • Strong communication skills (written and verbal)

Senior/Principal Scientist – Analytical/Bioanalytical Chemistry

Position Overview

The Senior Scientist will be part of a diverse team of analytical and bioanalytical chemists, synthetic chemists, molecular, and microbiologists and aid in various ongoing research and development activities. This position will have the opportunity to manage and lead projects within the company, collaborate with multidisciplinary teams, and gain exposure and training in GLP/cGMP work.

Essential Job Functions

  • Independently develop and validate analytical (or bioanalytical) methods for detection and quantitation of raw materials, drugs, metabolites, impurities, etc. in biological matrices, as well as in API or product formulations. Techniques include mass spectrometry (MS and MS/MS), HPLC/UPLC, UV-Vis, CAD, NMR, etc.
  • Formulate research and product development proposals and budgets for the company, setting corporate and departmental goals and priorities related to R&D.
  • Foster close cooperative relationships with all departments in the company. Work with the Business Development team and Senior Scientists to develop proposals for clients.
  • Support Quality Assurance to ensure all standard operating procedures are of high quality and are readily available for analysis. May serve as Study Director for GLP/cGMP projects with strict adherence to regulatory standards.
  • Supervise all study activities, with the chemistry team in terms of study initiation, data reporting and processing, and site management. Ensure the Chemistry department achieves project goals and budget targets in a timely manner.
  • Work interactively with all functions of the company and with Senior Scientists to help achieve the company’s vision.

Education and Requirements

  • Education: Ph.D. in Chemistry, Biochemistry, or a related field with a focus on analytical chemistry or bioanalyses, with a minimum of 3-5 years experience in R&D or equivalent work experience (e.g., post-doctoral research) preferred.
    M.S. in Chemistry, Biochemistry, or a related field with a focus on analytical chemistry or bioanalyses, with a minimum of 8-10 years experience in R&D or equivalent work experience will also be considered.
  • Required: 2-3 years of hands-on experience with LC-MS, MS/MS, and/or HRMS assay development for at least some of the following: peptides, antibodies, ADCs, small molecules, new chemical entities, and oligonucleotides.
  • Required: Experience with independently operating and troubleshooting mass spectrometers, relevant software platforms, subsequent data analyses, and interpretation.
  • Required: 2-3 years experience in one or more of the following areas: API and finished product analysis,
  • Required: strong communication skills (writing and speaking).
  • Preferred: experience with method transfer and subsequent qualification, such as from USP, EP, JP, etc. monographs.
  • Preferred: prior knowledge of the drug discovery/development pipeline.
  • Preferred: prior work experience in GLP/cGMP environment.
  • Preferred: 1-2 years of progressive management responsibility or equivalent work experience.

The above is not an exhaustive list of experiences/expertise required/preferred for this role. Candidates should feel free to highlight any specialized experience/expertise/accomplishments in their CV/resume and/or cover letter that they believe bolter the operations of a science-driven company within the general context of analytical chemistry/bioanalyses.

About Emery Pharma

Emery Pharma is a full-service Contract Research Organization (CRO) that delivers scientific solutions to accelerate pre-clinical drug development, support IND submissions, and enable drug substance and drug product analysis. Emery Pharma is located in the San Francisco Bay Area, focused on providing scientific solutions for the life science industry.

Company Benefits

We are prepared to offer the candidate a sign-on bonus and relocation package. Emery Pharma has a competitive compensation and benefits package including 90% of health, dental, and vision premiums, a 401k retirement plan with company contribution, and monthly performance bonuses.

Please send resume /C.V. with a cover letter to: [email protected]

Emery Pharma is an equal opportunity employer.