Director, Preclinical Drug Development
Zymeron Corporation Zymeron Corporation Durham, NC Durham, NC Full-time Full-time $100,000 - $200,000 a year $100,000 - $200,000 a year We are seeking an experienced drug development scientific director with demonstrated expertise from early-stage discovery to preclinical to clinical trial ready.
The Director of Preclinical Development will serve as a core member of our rapidly growing team to advance drug candidates from discovery to the clinic.
This position is an excellent opportunity for talented and motivated individuals seeking a scientific leadership role in a start-up environment developing a diverse pipeline of new molecular entities, reformulation, and repurposing.
The ideal candidate will have a track record of shaping preclinical programs to IND status and have the capability to effectively work across multiple domains of expertise.
Job Type:
Full Time Location:
Research Triangle Park, North Carolina Required Experience 1) Ph.
D.
in Medicinal Chemistry, Pharmaceuticals, Biochemistry, Bioengineering, or related field, with 10
years of drug development experience.
2) Minimum 3 years' experience in developing formulations for sterile parenteral administration in late preclinical to early clinical stage.
3) Expert knowledge of scientific principles related to pharmaceutical formulations and characterizations (dissolution, drug release, stability, content uniformity etc).
Strong technical foundation of understanding the functional relationships among formulation composition, process parameters, material characteristics and product performance.
4) Demonstrated expertise in developing drug stability studies including various stability indicating assays.
5) Experience in executing IND stage pharmacological and safety studies.
6) Understanding of Good Manufacturing Practices (GMP) and other applicable regulations (FDA, USP, EU) and experience in preparing CMC is a plus.
7) Expertise in drug development involving multiple platforms (small molecules, peptide drug conjugates, vaccines, nanomedicine) is preferred.
8) Proven leadership skills and problem-solving experience in drug development are preferred.
9) Demonstrated attention to detail.
Strong self-direction.
Description of Role 1) Assist in developing the company's preclinical research strategy.
2) Lead the design and execution of IND enabling study plans for small molecule drugs, peptide drug conjugates, and vaccines in Zymeron's pipeline.
3) Contribute to the selection of molecular entities and constructs to advance to IND-enabling studies and assist in the prioritization of pipeline.
4) Develop pre-formulation and formulation strategies for sterile parenteral administration drugs.
Determine formulation matrices that achieve required stability of small molecules, peptide drug conjugates, nanoparticle biologics conjugates (proteins and RNA) in liquid and lyophilized dosage forms.
5) Acquire broad knowledge of quality controls and regulatory requirements such as USP and CMC.
Ensure completion of study reports and relevant sections of pre-IND, IND, and other regulatory filings.
6) Design and lead studies to test hypotheses related to target product profiles.
Analyze data, evaluate results, form conclusions, and determine future experiments.
7) Present findings or project reviews at internal or external meetings.
Apply advanced technical writing skills to produce reports and proposals.
8) Coordinate technical transfer of new formulations and procedures for validation and scaling up to collaborator study sites.
9) Work with subject matter expert consultants on program specific needs.
10) Mentor junior scientific staff and act as a resource for providing scientific expertise in the development of new chemical entities, reformulation and repurpose of existing APIs.
What We Offer:
1.
Zymeron offers competitive paid leaves, vacations, flextime, health (medical, dental and vision) insurance, retirement plans, 401k matching, bonuses, stock options, and others.
2.
Zymeron participates in E-Verify Employment Verification.
3.
Zymeron is an equal opportunity employment (EOE) employer.
Job Type:
Full-time Pay:
$100,000.
00 - $200,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Relocation assistance Retirement plan Vision insurance Schedule:
8 hour shift Supplemental pay types:
Bonus pay Education:
Doctorate (Required) Work Location:
In person 1) Assist in developing the company's preclinical research strategy.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Director of Preclinical Development will serve as a core member of our rapidly growing team to advance drug candidates from discovery to the clinic.
This position is an excellent opportunity for talented and motivated individuals seeking a scientific leadership role in a start-up environment developing a diverse pipeline of new molecular entities, reformulation, and repurposing.
The ideal candidate will have a track record of shaping preclinical programs to IND status and have the capability to effectively work across multiple domains of expertise.
Job Type:
Full Time Location:
Research Triangle Park, North Carolina Required Experience 1) Ph.
D.
in Medicinal Chemistry, Pharmaceuticals, Biochemistry, Bioengineering, or related field, with 10
years of drug development experience.
2) Minimum 3 years' experience in developing formulations for sterile parenteral administration in late preclinical to early clinical stage.
3) Expert knowledge of scientific principles related to pharmaceutical formulations and characterizations (dissolution, drug release, stability, content uniformity etc).
Strong technical foundation of understanding the functional relationships among formulation composition, process parameters, material characteristics and product performance.
4) Demonstrated expertise in developing drug stability studies including various stability indicating assays.
5) Experience in executing IND stage pharmacological and safety studies.
6) Understanding of Good Manufacturing Practices (GMP) and other applicable regulations (FDA, USP, EU) and experience in preparing CMC is a plus.
7) Expertise in drug development involving multiple platforms (small molecules, peptide drug conjugates, vaccines, nanomedicine) is preferred.
8) Proven leadership skills and problem-solving experience in drug development are preferred.
9) Demonstrated attention to detail.
Strong self-direction.
Description of Role 1) Assist in developing the company's preclinical research strategy.
2) Lead the design and execution of IND enabling study plans for small molecule drugs, peptide drug conjugates, and vaccines in Zymeron's pipeline.
3) Contribute to the selection of molecular entities and constructs to advance to IND-enabling studies and assist in the prioritization of pipeline.
4) Develop pre-formulation and formulation strategies for sterile parenteral administration drugs.
Determine formulation matrices that achieve required stability of small molecules, peptide drug conjugates, nanoparticle biologics conjugates (proteins and RNA) in liquid and lyophilized dosage forms.
5) Acquire broad knowledge of quality controls and regulatory requirements such as USP and CMC.
Ensure completion of study reports and relevant sections of pre-IND, IND, and other regulatory filings.
6) Design and lead studies to test hypotheses related to target product profiles.
Analyze data, evaluate results, form conclusions, and determine future experiments.
7) Present findings or project reviews at internal or external meetings.
Apply advanced technical writing skills to produce reports and proposals.
8) Coordinate technical transfer of new formulations and procedures for validation and scaling up to collaborator study sites.
9) Work with subject matter expert consultants on program specific needs.
10) Mentor junior scientific staff and act as a resource for providing scientific expertise in the development of new chemical entities, reformulation and repurpose of existing APIs.
What We Offer:
1.
Zymeron offers competitive paid leaves, vacations, flextime, health (medical, dental and vision) insurance, retirement plans, 401k matching, bonuses, stock options, and others.
2.
Zymeron participates in E-Verify Employment Verification.
3.
Zymeron is an equal opportunity employment (EOE) employer.
Job Type:
Full-time Pay:
$100,000.
00 - $200,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Relocation assistance Retirement plan Vision insurance Schedule:
8 hour shift Supplemental pay types:
Bonus pay Education:
Doctorate (Required) Work Location:
In person 1) Assist in developing the company's preclinical research strategy.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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