Associate Scientist/Scientist, In Vitro Drug Metabolism / Pharmacokinetics
Xyzagen Xyzagen Pittsboro, NC Pittsboro, NC Full-time Full-time $70,000 - $85,000 a year $70,000 - $85,000 a year 9 days ago 9 days ago 9 days ago Xyzagen (Zi Za Gen) is a pharmacokinetics, ADME and bioanalytical contract research lab and drug development consultancy.
Xyzagen has worked with over 100 organizations supporting large and small molecules from early discovery through NDA approval and has provided strategic advice to early NIH funded biotechs, small and mid-size pharma and venture capital firms.
Our contract research focuses on early discovery pharmacology, pharmacokinetics, drug metabolism and bioanalysis, while our consultancy work focuses on strategic drug development consulting in the areas of ADME & Clinical Pharmacology.
In addition to our client-based work, we are developing our own proprietary research programs with a focus in pain and neurology indications.
We are seeking bright, highly motivated, and organized individuals who are interested in joining a dynamic, intellectually challenging, and a growing organization.
Successful candidates will be optimistic, solutions-oriented, accountable, and open-minded with a positive, can-do attitude and a strong ability to solve problems.
The Associate Scientist/Scientist, In Vitro Drug Metabolism/Pharmacokinetics, will provide scientific guidance and develop in vitro drug metabolism assays in support of client based work and internal research programs and support nonGLP and GLP nonclinical pharmacokinetics and toxicokinetics.
They will design and validate industry accepted in vitro ADME assays from start to data analysis to review of the validation report.
Upon completion of the validation of the assays, the Associate Scientist will work with clients conducting the in vitro assays that they have developed.
They will need to be knowledgeable regarding bioanalytical assay development utilizing mass spectrometry or absorption/fluorescence/ chemiluminescence plate reader bioanalytical assay development.
The individual may also actively identify new analytical technologies to analyze small molecules / drug candidates.
Moreover, the individual should have a basic understanding of pharmacokinetics and will be trained to use Phoenix Winnonlin.
The individual should have an understanding of the IND common technical document (CTD), regulatory/FDA compliance and excellent writing/presentation skills.
This position will range from Associate Scientist to Scientist depending on the individual's qualifications.
Individuals who will be successful in this role will be highly self-motivated and able to function independently with minimal supervision.
They will function with a high level of autonomy, will train others, and will run studies independently.
Additionally, strong time management skills are required to balance scientific oversight and project review/writing (50/50 split).
Job Requirements Education &
Experience:
Candidate will have a degree in Biology or Chemistry, Drug Metabolism, Pharmacokinetics or a related field Candidate will have work experience in this field MS with 2+year experience or Bachelor's degree with 4+year experience Candidates who have on the job drug metabolism experience with a degree in a scientific related field will also be considered.
Candidates who have on the job pharmacokinetics experience with a degree in a scientific related field will also be considered.
Qualifications:
Key skills/desired experience Proficiency in developing highly sensitive and specific bioanalytical methods for quantitative analysis of drug molecules Bioanalytical knowledge and extensive experience with analytical instrument platforms, particularly with Sciex and Agilent systems for LC/MS and Thermofisher Varioskan for ELISA/ Chemiluminescence Understanding of Sciex Analyst MS software Understanding of Agilent Chemstation software Experience with general maintenance of Sciex Mass Spec systems and Agilent HPLCs GLP experience and related expertise Knowledge of regulatory requirements and FDA compliance Knowledge of Certara's Phoenix Winnonlin software Ability to direct others from the start of experimental design to data analysis to review of final report Excellent writing and verbal presentation skills to internal and external audiences Advanced technical writing and scientific skills for making accurate assumptions from limited data and to assess / propose the next step in a development program Ability to train and oversee other members of the lab Exceptional time management and self-motivation Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is frequently required to sit or stand for extended periods of time; use fine and gross motor hand skills in ensuring analytical equipment is maintained in operation.
The employee must be able to speak and hear appropriately to communicate effectively with each associate or vendor.
The employee needs to be able to wear PPE when applicable.
The employee is regularly required to stand, walk, twist the torso, bend over and reach with hands and arms.
The employee on occasion will be required to lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close, distance and peripheral vision with the ability to adjust and focus.
Working Conditions:
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and fumes or airborne particles; toxic or caustic chemicals; blood borne pathogens (i.
e.
, urine, feces, blood, instruments, and sharps); dust and extremely hot water; and laboratory equipment.
The noise level in the work environment is usually mild to moderate.
Additional
Qualifications:
Programing skills in R computer language Rat/Mouse handling experience Hands-on experience with PK/PD software (e.
g.
, Phoenix WinNonlin and NLME) Benefits What We Offer:
A competitive salary and meaningful equity compensation A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology Exceptional opportunities for learning and growth Company-paid holidays (closed between Christmas and New Year's) Paid time off (2 weeks) Health benefit stipend 401(k) plan
Safe Harbor Match
Profit Sharing
Defined Benefit retirement plan Flexible time off for personal business is not tracked Ability to work from home when possible Flexible schedule Xyzagen is committed to the health and safety of employees and requires all employees be 100% vaccinated prior to starting employment unless they are granted a medical or religious exemption.
Xyzagen is a small company such that we are unable to sponsor visas for any candidate who is not eligible to work in the United States.
Additionally, we cannot assist with the transfer of an employment visa from another company.
NybU330xAv.
Estimated Salary: $20 to $28 per hour based on qualifications.
Xyzagen has worked with over 100 organizations supporting large and small molecules from early discovery through NDA approval and has provided strategic advice to early NIH funded biotechs, small and mid-size pharma and venture capital firms.
Our contract research focuses on early discovery pharmacology, pharmacokinetics, drug metabolism and bioanalysis, while our consultancy work focuses on strategic drug development consulting in the areas of ADME & Clinical Pharmacology.
In addition to our client-based work, we are developing our own proprietary research programs with a focus in pain and neurology indications.
We are seeking bright, highly motivated, and organized individuals who are interested in joining a dynamic, intellectually challenging, and a growing organization.
Successful candidates will be optimistic, solutions-oriented, accountable, and open-minded with a positive, can-do attitude and a strong ability to solve problems.
The Associate Scientist/Scientist, In Vitro Drug Metabolism/Pharmacokinetics, will provide scientific guidance and develop in vitro drug metabolism assays in support of client based work and internal research programs and support nonGLP and GLP nonclinical pharmacokinetics and toxicokinetics.
They will design and validate industry accepted in vitro ADME assays from start to data analysis to review of the validation report.
Upon completion of the validation of the assays, the Associate Scientist will work with clients conducting the in vitro assays that they have developed.
They will need to be knowledgeable regarding bioanalytical assay development utilizing mass spectrometry or absorption/fluorescence/ chemiluminescence plate reader bioanalytical assay development.
The individual may also actively identify new analytical technologies to analyze small molecules / drug candidates.
Moreover, the individual should have a basic understanding of pharmacokinetics and will be trained to use Phoenix Winnonlin.
The individual should have an understanding of the IND common technical document (CTD), regulatory/FDA compliance and excellent writing/presentation skills.
This position will range from Associate Scientist to Scientist depending on the individual's qualifications.
Individuals who will be successful in this role will be highly self-motivated and able to function independently with minimal supervision.
They will function with a high level of autonomy, will train others, and will run studies independently.
Additionally, strong time management skills are required to balance scientific oversight and project review/writing (50/50 split).
Job Requirements Education &
Experience:
Candidate will have a degree in Biology or Chemistry, Drug Metabolism, Pharmacokinetics or a related field Candidate will have work experience in this field MS with 2+year experience or Bachelor's degree with 4+year experience Candidates who have on the job drug metabolism experience with a degree in a scientific related field will also be considered.
Candidates who have on the job pharmacokinetics experience with a degree in a scientific related field will also be considered.
Qualifications:
Key skills/desired experience Proficiency in developing highly sensitive and specific bioanalytical methods for quantitative analysis of drug molecules Bioanalytical knowledge and extensive experience with analytical instrument platforms, particularly with Sciex and Agilent systems for LC/MS and Thermofisher Varioskan for ELISA/ Chemiluminescence Understanding of Sciex Analyst MS software Understanding of Agilent Chemstation software Experience with general maintenance of Sciex Mass Spec systems and Agilent HPLCs GLP experience and related expertise Knowledge of regulatory requirements and FDA compliance Knowledge of Certara's Phoenix Winnonlin software Ability to direct others from the start of experimental design to data analysis to review of final report Excellent writing and verbal presentation skills to internal and external audiences Advanced technical writing and scientific skills for making accurate assumptions from limited data and to assess / propose the next step in a development program Ability to train and oversee other members of the lab Exceptional time management and self-motivation Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is frequently required to sit or stand for extended periods of time; use fine and gross motor hand skills in ensuring analytical equipment is maintained in operation.
The employee must be able to speak and hear appropriately to communicate effectively with each associate or vendor.
The employee needs to be able to wear PPE when applicable.
The employee is regularly required to stand, walk, twist the torso, bend over and reach with hands and arms.
The employee on occasion will be required to lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close, distance and peripheral vision with the ability to adjust and focus.
Working Conditions:
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and fumes or airborne particles; toxic or caustic chemicals; blood borne pathogens (i.
e.
, urine, feces, blood, instruments, and sharps); dust and extremely hot water; and laboratory equipment.
The noise level in the work environment is usually mild to moderate.
Additional
Qualifications:
Programing skills in R computer language Rat/Mouse handling experience Hands-on experience with PK/PD software (e.
g.
, Phoenix WinNonlin and NLME) Benefits What We Offer:
A competitive salary and meaningful equity compensation A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology Exceptional opportunities for learning and growth Company-paid holidays (closed between Christmas and New Year's) Paid time off (2 weeks) Health benefit stipend 401(k) plan
Safe Harbor Match
Profit Sharing
Defined Benefit retirement plan Flexible time off for personal business is not tracked Ability to work from home when possible Flexible schedule Xyzagen is committed to the health and safety of employees and requires all employees be 100% vaccinated prior to starting employment unless they are granted a medical or religious exemption.
Xyzagen is a small company such that we are unable to sponsor visas for any candidate who is not eligible to work in the United States.
Additionally, we cannot assist with the transfer of an employment visa from another company.
NybU330xAv.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
