AD Scientist

Job Description:

GENERAL SUMMARY:

The AD Scientist is a senior technical team member reporting to a group leader in R&D Services. The candidate has advanced theoretical and practical understanding of technical discipline and is adept at independently designing, executing, interpreting, summarizing and presenting results to clients or Cytovance teams. He or she provides significant contributions to client projects, including analytical method development, transfer and qualification according to regulatory guidelines, and by doing so helps the group leader to meet timeline and scope commitments of multiple client projects in parallel.  Routinely, the candidate is expected to provide on-the-job training to junior colleagues. May supervise junior colleagues providing guidance, coaching and career development support.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

•    Possesses sound understanding of major technologies: lab techniques, analytical methods, bioprocessing, and purification methods.
•    Possesses good knowledge of method development and qualification/validation guidelines (ICH, FDA).
•    Possesses strong knowledge of and leads development of more than 50% of analytical techniques with supervision including: SE-HPLC, RP-HPLC, ELISA, SDS-PAGE, CE-SDS, cIEF, and Octet.
•    Effectively troubleshoots method issues by developing hypotheses, designing experiments to test the hypotheses, and critically evaluating data.
•    Prepares reports on analytical methods and method development/transfer summaries with emphasis on critical steps, mathematical calculations and statistical data.
•    Independently drafts standard operating procedures (SOPs), method qualification protocols and reports in accordance with ICH and FDA guidelines.
•    Effectively conveys complex scientific concepts (written and oral)
•    Stays current with all training requirements. 
•    Follows procedures reliability and consistently.
•    Sets up experiments, monitors, and acquires analytical data.
•    Keeps detailed, accurate and clearly written records in accordance with GDPs.
•    Maintains and troubleshoots general laboratory maintenance (e.g. material ordering, inventory management, record management, general housekeeping, equipment). 
•    Effectively troubleshoots method issues by developing hypotheses, designing experiments to test the hypotheses, and critically evaluating data.
•    Prepares reports on analytical methods and method development/transfer summaries with emphasis on critical steps, mathematical calculations and statistical data.
•    Independently drafts standard operating procedures (SOPs), method qualification protocols and reports in accordance with ICH and FDA guidelines.
•    Establishes good working relationships with peers and other colleagues.
•    Displays a positive attitude and good change readiness.
•    Independently supports good lab hygiene.
•    Uses own scientific judgment to apply and adapt standard methods and techniques with increased independence by applying prior work experience. High awareness of personal limitations and proactively consults others to ensure quality of judgment.
•    Works independently on assignments using knowledge and work experience. Proactively gathers input from colleagues to assist with novel (to them) aspects of the job.
•    Work is performed under minimal supervision. Completed work is reviewed by supervisors for timely and accurate achievement of results.
•    Makes decisions that require developing new options to solve moderately complex problems.
•    Works in ambiguous situations. Mitigates uncertainty of successful scientific outcome by parallel approaches or by complexity of experimental designs and controls.
•    May supervise or mentor other colleagues providing guidance, coaching and career development support.
•    Other duties as assigned. Serves as a significant contributor with subject matter expert to develop and provides mass spectrometry services.
•    Proficient general computer skills (e.g. Microsoft office, excel, word, powerpoint).

JOB REQUIREMENTS:

•    A bachelor’s or master’s degree in analytical chemistry, biochemistry, microbiology, biology, chemistry or chemical engineering. 
•    A Ph.D. in relevant discipline is desirable.
•    1-4 years of prior research experience in a development capacity involving one or more of the following technical areas; recombinant protein expression, buffer and media design and preparation, fed-batch fermentation process development for biologics, animal cell culture process development for biologics, microbiology, primary recovery development, protein purification process development, bioanalytical and analytical method development, characterization of proteins, scale-up and tech transfer
•    Has advanced knowledge of a specialized discipline and working knowledge of principles and concepts in other relevant technical disciplines.
•    Excellent written and verbal communication skills.
•    A growing track record for publication or technical content authoring.

PHYSICAL DEMANDS:  
 
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

WORK ENVIRONMENT:  

While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals consistent with a lab environment. The noise level in the work environment is usually moderate.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic’s requirements prior to transmitting any Resumes/CV’s or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic’s Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.