Director of CMC

Eitr Biologics, Inc., (Eitr) is a San Diego, CA based biotechnology company focused on the pursuit of novel next generation immunotherapeutics for the treatment of infectious diseases that are a current or emerging threat to public health. Our scientific approach emphasizes the development of technologies that will increase global accessibility to lifesaving immunotherapeutics. Eitr has fostered a robust and highly collaborative worldwide network of academic and government laboratories that share in our scientific goal to address unmet public health needs. Eitr scientists can expect to work in a collaborative atmosphere to advance promising early-stage exploratory technologies to clinical stages of drug development.

Eitr currently has an opening for a Director of CMC. The Director of CMC will play a crucial role in our organization, overseeing all aspects of CMC activities related to early-stage drug development, while continuing to support products as they transition into later stages of development. The position will focus on developing platform manufacturing and analytical methods for novel immunotherapeutics. The ideal candidate will possess a deep understanding of biopharmaceutical manufacturing processes, analytical method development, regulatory compliance, and team leadership.

Responsibilities

• Effectively manage a team of scientists and research associates to meet CMC-related project goals
• Presents findings in the form of study reports, powerpoint presentation, or other relevant format
• Manages downstream processing of antibody and/or camelid VHH (aka nanobody) containing supernatants from mammalian, yeast and prokaryotic expression platforms
• Develops stage-appropriate analytical methods to measure product potency, identity, purity and stability
• Gathers key-data to support the proposed strategy of purifying recombinant proteins, monoclonal antibodies (mAbs), or VHHs from clarified culture supernatants from a small to large scale
• Develops strategies for concentration/buffer exchanges using Amicon filter unit or TFF system
• Continually evaluates and assesses the use of novel resins and/or techniques and methodologies to optimize downstream processing of the proteins of interest
• Has the ability to seamlessly move between the Discovery and Development phase to take on scientific assignments that move programs currently the clinical phase of development
• Understands and applies the differences between development, qualified and validated methods depending upon the work product assigned
• Writes experimental summaries and technical reports in digital lab notebook
• Other duties as assigned

Basic Qualifications

• PhD with 10 years of experience or a Bachelor's degree in with at least 20 years of experience in a related scientific discipline
• Experience managing a team of scientists and research associates
• Ability to effectively communicate findings to leadership, other groups within the company, and outside stakeholders
• Experience utilizing the chromatography resins and membranes listed below:
  • Protein A or Protein G for antibody or VHH purification protocols
  • Anion-exchange resins or membranes such as Capto Q and/or Polisher ST
  • Cation-exchange or multimodal resins such as Capto S ImpAct, and CHT II (Ceramic Hydroxyapatite)
• Successfully executed formulation, concentration feasibility, and stability studies
• Continually evaluates and assesses the use of novel resins and/or techniques and methodologies to optimize downstream processing of the proteins of interest
• Experience in designing and developing methods for analytical assays listed below:
  • UV Spectrophotometry for determining protein concentration
  • Size-exclusion HPLC (SEC) for measuring aggregate/fragmentation levels and other possible contaminants
  • Cation-exchange HPLC (cIEX) for detection of charge variants and product identity
  • Determination of endotoxin contamination/levels using Endosafe PTS system
  • Capillary Electrophoresis (CE) based assays such as CE-SDS, cIEF, etc
  • Quantification of Host-Cell Protein (HCP) contamination and Residual Protein A (rPrA) via ELISA-based methods
  • Detection and quantification of Host-Cell DNA (hcDNA) via qRT-PCR based methods
  • Measurement of protein-protein binding kinetics via ELISA (EC50) or BLI (KD)

Preferred Qualifications

• Experience with electronic or digital lab notebooks and data entry
• Experience in the field of infectious disease immunotherapeutics
• Experience developing analytical methods to support characterization of engineered recombinant proteins and/or antibodies
• Experience working with disulfide rich peptides and/or proteins
• Large scale purification experience and material formulation for large animal studies

Physical Demands of the Position Offered

The physical demands described here are representative, but not exhaustive, of those that must be met by an employee to successfully perform the essential functions of this laboratory position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• On-site role: This is a full-time position that requires the employee to physically report to the jobsite.
• Lifting and Carrying: This position may require the ability to lift and carry laboratory equipment, glassware, and supplies weighing up to 40 pounds on occasion. Employees should be able to safely use appropriate equipment and follow proper lifting techniques.

• Fine Motor Skills: Precise fine motor skills are essential for tasks such as pipetting and operating delicate laboratory equipment. Candidates should demonstrate manual dexterity and hand-eye coordination.

• Standing and Walking: Laboratory work often involves prolonged periods of standing and walking while conducting experiments, monitoring equipment, and moving between workstations.

• Sitting: Data analysis, documentation, and report writing are integral aspects of this role, requiring the ability to sit at a desk or workstation for extended periods.

• Bending, Stooping, and Reaching: Employees may be required to bend, stoop, and reach to access equipment, samples, or materials on upper or lower shelves or within laboratory hoods. These activities may involve climbing ladders, stairs, step stools, or other structures. Candidates should be able to safely perform these tasks.

• Vision: Good vision is essential for tasks such as reading labels, observing specimens, and using microscopes. Corrected vision and color vision may be required for accurate analysis.

• Hearing: Laboratory environments may include equipment that produces noise. Adequate hearing is necessary for communication and safety awareness.

• Use of Laboratory Equipment: Proficiency in the safe operation of laboratory equipment, including centrifuges, microscopes, and pipettes, is expected.

• Laboratory Safety: Compliance with safety protocols, including the use of personal protective equipment (PPE) such as lab coats, gloves, safety goggles, and respiratory protection where required is mandatory.

• Chemical Handling: The handling of chemicals and biological materials is a fundamental aspect of bioscience laboratories. This may include the ability to safely handle and transport hazardous materials.

• Working with Biological Agents: Some positions may involve working with biological agents, which may require adherence to specific safety protocols and vaccinations.

• Team Collaboration: Effective communication and collaboration with team members are essential for data sharing, experimental planning, and project coordination.

Candidates should be aware that the physical demands listed above are general guidelines and may vary depending on the specific role and workplace. It is important for applicants to inquire further about the physical requirements during the interview process to ensure they can perform the job safely and effectively.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance
• Paid Time Off (Vacation, Sick & Holidays)
• Family Leave (Maternity, Paternity)
• Training & Development

Compensation

Eitr reasonably expects the annual base compensation for this role to be between $165,000 and $200,000. Specific offer details are determined by carefully considering a variety of factors, including the candidate’s skills, experience, education, market demands, and internal parity.

EEO Employer

Eitr is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Eitr is also committed to providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please let us know the nature of your request and your contact information.

Eitr is not currently hiring foreign national applicants that require or will require sponsorship tied to a specific employer, such as H, L, TN, F, J, E, O.

Salary : $165,000 - $200,000