Job Description
Job Description
Candidates must demonstrate experience in: the understanding of medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
Programmatic / Technical Advisor Qualifications:
Minimum of Five (5) years of relevant industry experience
with
Bachelor’ s degree Graduate (preferred) in biological and/or chemical sciences with relevant experience
or
post graduate degree(s) in medicine or pharmacy or with commensurate experience(s) bachelor's degree in computer science, Statistics, or related fields Extensive knowledge and experience in clinical trials and epidemiological research including three (3) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred.
Bachelor's degree (graduate preferred) appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)
Or
relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions, application of degree in biology, chemistry, or pharmacy with commensurate experience.
Or
a bachelor's degree in chemistry, Engineering or Biology including five (5) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
*Or equivalent*
Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of one year (52 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).
Mid-Level Programmatic / Technical Advisor Qualifications:
Minimum of eight (8) years of relevant industry experience
with
Graduate or advanced degree in biological and/or chemical sciences and/or relevant postdoctoral experience.
or
clinical studies: application of an advanced degree(s) in medicine or pharmacy or with commensurate experience(s)
master's degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including five (5) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH guidelines and CDISC data standards preferred.
Advanced degree in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or master’s (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)
Or
relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions; application of degree in biology, chemistry, or pharmacy with commensurate experience.
Or
a bachelor's degree in chemistry, Engineering or Biology including eight (8) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
*Or equivalent*
Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of three years (156 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).
Senior Programmatic / Technical Advisor Qualifications:
Minimum of Twelve (12) years of relevant experience
with
doctoral degree in biological and/or chemical sciences with relevant postdoctoral experience
or
clinical studies: application of doctoral degree(s) in medicine or pharmacy or with commensurate experience(s)
advanced degree in computer science, Statistics, or related fields. Extensive knowledge and experience in clinical trials and epidemiological research including seven (7) years of direct statistical programming experience with strong programming skills in SAS, R, and other statistical software. Extensive knowledge of FDA/ICH
guidelines and CDISC data standards preferred. PhD in appropriate life sciences field (immunology, molecular biology, biochemistry, microbiology, or similar), or Masters or Bachelors (with commensurate experience) of science in a physical science field (engineering, physics, computer science, or similar)
Or
relevant industry experience (listed) in pharmaceutical industry regulatory affairs and/or quality assurance and /or quality control positions, application of degree in biology, chemistry, or pharmacy with commensurate experience.
Or
a bachelor's degree in chemistry, Engineering or Biology including ten (10) years of direct experience in pharmaceutical facility architecture and application in commercial building construction or a degree in business with experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
*Or equivalent*
Waiver maybe issued by the government if the proposed candidate has a combination minimum of years of industry experience and/or degree in desired discipline ALONG with a minimum of five years (260 weeks) of direct experience supporting organizations related to Advanced Research and Development (ARD) and Medical Countermeasures (MCM).
*Salary Based on Experience