This position is based in Irving, Texas with as needed travel to contract manufacturing organizations.
Proficient in small molecule pre-formulation development and solid-state characterization selection work to support candidate selection through to IND submission.
Perform pre-formulation evaluation and necessary physical and chemical characterization to support new chemical entity assessment of Reata discovery candidates purposed for clinical development.
Enable early candidate selection by physicochemical profiling and participate in discovery teams.
Lead or perform early development activities on API and intermediates such as physiochemical characterization, solubility, dissolution and stability assessments (HPLC), as well as formulation development for GLP toxicology & pharmacokinetic studies.
Familiarity with bioavailability enhancing formulation technologies, and their utility with product development.
Skilled with physiochemical characterization tools such as XRPD, DSC, TGA, Raman and FTIR analysis, particle analysis, polarized light microscopy and vapor sorption analysis.
Knowledgeable in the design and execution of polymorph and salt screen studies.
Responsible for review and quality control of CMC documentation across RTA early development programs.
Review characterization, analytical method and associated validation reports to assure suitability for regulatory submissions.
Reviews CMO CMC documentation as needed working as part of the CMC team to support the on-going needs at GMP CMO’s.
Demonstrate commitment and support for company goals, objectives and procedures.
Represent Reata by developing collaborative relationships with site personnel, colleagues and vendors.
Demonstrate professionalism and adherence to moral, ethical and quality principles.
Participate in departmental meetings.
Actively communicate with Reata colleagues to facilitate project goals.
INDUSTRY REQUIRED QUALIFICATIONS:
Ph.D. in Pharmaceutics, Analytical/Organic Chemistry, 5+ years' directly relevant pharmaceutical experience or a Master’s Degree in a similar discipline with 8+ years' experience in a similar role
Demonstrated knowledge of the critical factors that influence formulation aspects for novel drug candidates.
Well versed with contemporary scientific literature appropriate for providing successful leadership in pre-formulation activities.
Demonstrated skills in critical document review, project organization and execution, independent thinking, time structure and self-management and detail-oriented project management
Knowledge and understanding of the fundamentals of analytical chemistry with an established track record of accomplished learning
Strong verbal and technical writing skills
Excellent analytical and problem-solving skills
Comfortable working in a small company team environment where activities may be outsourced.
Ability and willingness to travel domestically (up to 10%) and internationally (0- 5%) to meet organizational objectives and goals.
About Reata Pharmaceuticals
At Reata Pharmaceuticals, our mission is to develop innovative therapies that change patients’ lives for the better.
We’re committed to positively impacting the lives of patients with life- threatening diseases. With rigorous science and research as our foundation, we are a team of problem solvers, trail blazers, and people who want to make a difference. Our ideal candidates are those who are excited by a challenge and driven to succeed.
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