Scientific Director Biotherapeutics

COMPANY OVERVIEW

Inotiv, Inc., is a publicly listed drug discovery and development company with more than 500 employees at 6 sites. Originally founded in 1974 under the name Bioanalytical Systems, Inc. (BASi), the company was reinvented in 2017 when current leadership launched a new strategic plan and vision to become the preferred, “solutions-oriented” CRO. Our headquarters are in West Lafayette, Indiana. 

Inotiv provides contract research services on innovative approaches to drug discovery and development for and with emerging pharmaceutical companies and the world’s leading drug development companies and medical research organizations. By assembling top-class scientists, state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas, Inotiv has a strong foundation to continue our unique leading position as a contemporary drug discovery and development company.

POSITION SUMMARY

To support our continued growth, Inotiv is seeking a career-minded candidate to join our team as Scientific Director within our new Biotherapeutics GLP laboratory. In this role, the Scientific Director will report into the Vice President, Bioanalytical Sciences and be responsible for the oversight of all scientific aspects of this biotherapeutics laboratory, including method development and validation for large molecules (peptide/protein therapeutics), monoclonal antibodies, oligonucleotides, cell and gene therapies, ADCs (PK and immunogenicity) and the whole spectrum of biomarkers. The Director will oversee all scientific aspects in the lab and provide guidance on development and validation of these methods to meet the standards for MDV as prescribed by the FDA, EMA, and other Regulatory bodies to fully comply with GLP and GCLP guidelines. Continuous adaption will be required to scale to ensure the department delivers optimal performance as bioanalytical sciences undertakes a broad spectrum of therapeutics in the drug discovery as well as the clinical arena in the future. The Director will also work closely with the small molecule bioanalytical laboratory for any LC-MS/MS techniques required for some of these biotherapeutic drugs.  

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Lead a team of >6 scientists/senior and technical staff responsible for bioanalytical method development (PK/PD, immunogenicity), validation and sample management/analysis in support of preclinical and clinical drug development on a scientific level.
• Collaborate with scientific discipline leaders in DMPK, Toxicology, Pharmacology and biomarkers to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv’s client base.
• Ensure compliance is maintained, continuing Inotiv’s phenomenal track record of successful FDA audits.
• Embrace a highly visible role, providing bioanalytical method development expertise and validation project scope to internal and external clients, in collaboration with Business Development.
• Actively participate and collaborate with multidisciplinary teams charged with the design, execution and direction of IND enabling projects; thereafter taking a supporting role in delivering the full package to current and prospective clients.
• Generate and build consensus on communication plans for all major method development & validation projects; gather input from department managers, sponsors, PIs and laboratory support functions.
• Regularly review method development progress, issues, and failures with internal and external project teams in a collaborative and supportive manner.
• Collaborate with Inotiv’s Discovery DMPK Group Leadership regarding bioanalytical method development projects and in anticipation of discovery-to-development stage gate transition of client assets and projects.
• Create, maintain, and improve standardized tools for method development and validation activities; identify opportunities for automation to increase speed and efficiency.
• Manage team priorities and resource allocation for the method development team in pursuit of operational capacity and growth, without any sacrifice to quality and client service.
• Promote an open and communicative culture; foster a team environment that aligns with Inotiv’s culture and promotes the pursuit of maximizing potential.
• Continuously elevate the organization through effective retention and recruiting strategies 
• Ensure employees receive effective coaching, mentoring, and training to support growth and development on a consistent and regular basis.
• Identify new approaches, methodology, and/or the advent of state-of-the-art equipment.
• Bioanalytical Assays and Immunology
  1. Leader of team of scientists that develop, validate and execute a wide variety of biological assays including PK, immunogenicity, genomic, various biomarker assays, including DNA, RNA, soluble protein markers, flow assays and cell-based assays.
  2. Provide in-depth scientific guidance for experimental strategies to measure state-of-the-art biological endpoints and their response to experimental treatments; endpoints include cancer phenotypes, immune cell populations and activation states, gene expression, cell-cycle and signal transduction pathways.
  3. Work with the laboratory manager to manage activities such as scheduling of experiments, acquisition of materials, coordination with aligned groups for execution, and completion of data analysis and reporting.
• Staff and Technical Development
  1. Provide a culture of learning and development opportunity for scientific staff. Instruct staff as needed.
  2. Develop strategic plans for hiring to meet growing demand and changing technologies. Oversee hiring process and staff development through performance management and promotion.
  3. Develop and oversee the implementation of departmental scientific training programs
• Business Development
  1. Participate in discussions with customers to represent capabilities and provide strategic guidance to achieve experimental goals.
  2. Partner with designated client services representatives to ensure the production of timely, high quality research proposals.
  3. Partner with project managers/study directors to effectively implement customer requested study changes and communicate progress.

PROFESSIONAL QUALIFICATIONS:

Education/Experience:

• Ph.D. in Immunology, molecular biology, bioanalytical chemistry, drug metabolism, pharmacokinetics or related science with 10+ years of bioanalytical experience in the pharmaceutical industry or a drug discovery & development or clinical CRO.
• Biotherapeutics, Biomarker and technical experience required - Small molecule experience is desirable.
• Experience in method development and validation of large molecules for PK, ADA and NAb using ELISA, MSD, PCR and cell-based assays for e.g., proteins, peptides, monoclonal antibodies, oligonucleotides, cell and gene therapy products essential.   Knowledge on other biomarker analysis including flow analysis preferable.
• Experience leading a complex method development and validation team in a GxP environment. 
• Experience interfacing with sponsors/clients on a wide range of bioanalytical method development projects.

Skills, Specialized Knowledge and Abilities:

• Leadership acumen with solid influencing skills necessary to drive change effectively and cross functionally.
• Demonstrated expertise in bioanalytical chemistry best practices and processes.
• Understanding of GLP/GCP/GMP/GCLP regulations; ability to apply practices daily.
• Excellent written and verbal communication skills (English required); open, interactive style that facilitates high levels of trust.
• Business development/sales acumen, capable of promoting and educating clients on services that meet their needs and/or challenges.
• Exceptional project management and organizational skills.
• Expert presentation skills related to complex or controversial topics to internal and external audiences.
• Exceptional partnering and collaboration skills with stakeholders at all levels.
• Superior interpersonal skills that demonstrate high levels of emotional intelligence and critical thinking.
• Self-starter, capable of working independently to generate desired results.
• Proficiency with MS Office Suite products.
• Expert knowledge of ELISA, MSD, PCR, flow cytometry instruments for biotherapeutics and biomarkers.

PROFESSIONAL RESPONSIBILITIES: (if applicable)

• Attends continuing education courses, as appropriate.
• Maintain an active involvement in professional organizations.
• Be knowledgeable in regulatory requirements.

At Inotiv our team members come together in support of an organization focused on delivering the experience, knowledge, and responsiveness demanded from an industry striving to bring new cures to market more safely and faster than ever before. Come join our team!  

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, 401K participation with company match, etc. 

Inotiv is an equal opportunity employer and an E-Verify employer.