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Senior Manager, Chemistry, Manufacturing and Controls

What You Will Do

On Target Laboratories’ vision is to brighten the future for those fighting cancer by making cancer visible intraoperatively so it can be removed more completely.

On Target outsources all cGMP manufacturing and testing.  This activity requires sound technical support and input to enable the successful transfer of technology from On Target to manufacturing partners to support clinical studies and develop programs that are ready for commercialization.

The Senior Manager, Chemistry, Manufacturing and Controls reports to the Vice President of Chemistry, Manufacturing and Controls (CMC)

Responsibilities:

  • Oversee development of synthetic processes for regulatory starting materials (RSMs) and drug substance (DS) at Contract Manufacturing Organizations (CMOs) including review of development reports.
  • Oversee stability programs at CMOs
  • Oversee development and validation of analytical methods for RSMs and DS including review of validation protocols and reports.
  • Support Manufacturing operations at CMOs including on-site support as applicable.
  • Oversee manufacturing process validation.
  • Oversee activities required to support regulatory filings such as but not limited to establishment of retest period/shelf life through stability studies, establishment of specifications, establishment of proper controls (critical process parameters, In-process controls and release criteria), identification and tracking of impurities.
  • Support drafting Module 3 for regulatory filings.

Who We Are Looking For

Unconventional Thinkers. People who question why things are done, are always coming up with a better way, and are not intimidated by taking risks.

Relentless Achievers. People who thrive in a fast-pace entrepreneurial environment and will stop at nothing to accomplish their goals.

Inspirational Collaborators. People who bring others with them and build teams, who foster the strength which comes from diverse individuals working toward a common goal. Team building is our culture, and One Team is the foundation for the Company.

Required Qualifications:

  • Ph.D. in organic chemistry or chemical engineering with 8+ years of experience.
  • Understanding of phase appropriate process controls and method validation. Experience with developing robust manufacturing processes for small molecules.
  • Demonstrated understanding of GMP Compliance requirements and Quality Management Systems for the preparation of clinical and commercial materials.
  • Experience with preparing documentation to support regulatory filings.
  • Must be highly organized, possess impeccable documentation practices and have an extraordinary attention to detail.
  • Strong written and verbal communication skills and demonstrated ability to work well independently and collaboratively with cross functional teams.

Location & Travel Requirements

This position is located in the United States and is a primarily virtual position with up to 25% travel.

Who We Are:

On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery so cancerous tissue can be removed more completely. Our molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University’s Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX (pafolacianine) injection, the Company’s first product, received FDA approval in November 2021 for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. For more information visit www.ontargetlabs.com and www.cytalux.com.

This is a benefits eligible, exempt position. Please submit cover letter and CV to [email protected].

On Target Laboratories, Inc. is an Equal Opportunity Employer. On Target Laboratories, Inc. does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need

Senior Manager, Quality Assurance

What You Will Do

On Target Laboratories’ vision is to brighten the future for those fighting cancer by making cancer visible intraoperatively so it can be removed more completely. The Senior Manager, Quality Assurance will be responsible for supporting the administration and management of the company’s Quality Management System and provide quality support for all the departments at On Target Laboratories.

The Senior Manager Quality Assurance reports to the Director, Quality.

Responsibilities:

  • Support and provide input on all aspects of the company quality management system including but not limited to:
    • Maintain quality documents such as SOPs, policies, company templates and quality manual.
    • Assist the Head of Quality in SOP gap identification, manage SOP development, revisions, and approvals.
    • Review all company procedures and policies and confirm compliance with the company quality manual.
  • Conduct or facilitate internal and external audits and drafting annual auditing plans.
  • Facilitate and provide input on all company investigations, deviations, and CAPAs.
  • Support of the CMC department including review and approval of Contract Manufacturing Organization (CMO) protocols and reports, batch records, batch release documentation, deviations, investigations including, out of specifications (OOS) investigations, and change controls.
  • Support the Clinical Operations department as needed including but not limited to vendor selection and qualification, audits of vendors, investigational sites, and/or clinical trial documents, preparation for and facilitation of regulatory agency inspections, communication of best practices and lessons learned from inspections, development and tracking of CAPAs to ensure proper resolution, training assistance related to GCP procedures, and development and implementation of a clinical quality management system.
  • Support all Quality Assurance responsibilities pertaining to the maintenance of the supply chain temperature excursions, product quality complaint, and product recalls.
  • Review and provide input to regulatory submissions to the IND and NDA.
  • Provide support to functional groups (R&D, CMC, Clinical, Commercial) on quality requirements and quality compliance.
  • Provide support in the oversight and guidance to external suppliers, CMOs and contract testing labs.
  • Conduct training for new hires as needed.

Who We Are Looking For

Unconventional
Thinkers. People who question why things are done, are always coming up with a better way, and are not intimidated by taking risks.

Relentless Achievers. People who thrive in a fast-pace entrepreneurial environment and will stop at nothing to accomplish their goals.

Inspirational Collaborators. People who bring others with them and build teams, who foster the strength which comes from diverse individuals working toward a common goal. Team building is our culture, and One Team is the foundation for the Company.

Required Qualifications:

  • Bachelor’s degree with minimum 8 years’ experience in regulatory or QA environment and excellent working knowledge of GMP, GLP, GCP, GDP, ICH, and FDA regulations.
  • Must be highly organized, possess impeccable documentation practices and have extraordinary attention to detail.
  • Experience interfacing with FDA, vendor, investigational site, and/or customer audits.
  • Experience with CAPA identification and resolution.
  • Experience with sterile manufacturing is preferred.
  • Excellent management, and self-direction experience: strong interpersonal communication and problem-solving skills.
  • Strong written and verbal communication skills and demonstrated ability to work well in project teams.
  • FDA audit experience.

Location & Travel Requirements
This position is located in the United States and is a primarily virtual position with up to 30% travel.

Who We Are

On Target Laboratories discovers and develops targeted intraoperative molecular imaging agents to illuminate cancer during surgery so cancerous tissue can be removed more completely. Their molecular imaging technology, based on the pioneering work of Philip S. Low, PhD, Purdue University’s Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry, are comprised of a near-infrared dye and a targeting molecule, or ligand, that binds to receptors overexpressed on cancer cells. The imaging agents illuminate the cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.  CYTALUX (pafolacianine) injection, the Company’s first product, received FDA approval in November 2021 for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. For more information visit www.ontargetlabs.com and www.cytalux.com.

This is a benefits eligible, exempt position. Please submit cover letter and CV to [email protected].

On Target Laboratories, Inc. is an Equal Opportunity Employer. On Target Laboratories, Inc. does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Interested in joining the team?

 

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