Vacancy expired!
Job Description
Employee Responsibilities:
- Author technical protocols for studies, works with the drug product (DP) lead to ensure appropriate design of experiments, sample size selection and appropriate acceptance criteria
- Author or performs second-person review (SPR) technical reports that can be used as source documentation for regulatory filing
- Write and close out electronic laboratory notebooks
- Second Person Review of laboratory notebooks
- Support to regulatory filing authoring and/or review
- Lab-scale support of commercialization / process development activities.
- Interaction with cross-functional team members to identify parameters to be examined and design studies that will provide meaningful results with the least amount of time/resources
- Formulation and filling of biologic, vaccine, and small molecule pharmaceutical products
- Support new product introduction and process validation at commercial sites
- Ensure compliance to safety and documentation requirements when performing experiments in the lab.
- Ensure technical information is clearly understood and integrated into decision making. Make conclusions/recommendations based on sound review of data or scientific literature.
- Effectively summarize and present results and recommendations at meetings and technical review sessions
- Responsible for sample submission and tracking. Employs statistical tools and methods to analyze results.
- Ensures safety and documentation compliance with performing experiments in the lab.
- Contribute to a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity and inclusion
The Ideal Candidate would possess:
- Strong scientific, computer, organizational, and documentation skills
- Excellent interpersonal, communication (oral and written), and collaboration skills and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Knowledgeable of GMPs as applied to manufacturing of biologics and vaccines
- Analytical problem-solving skills
- Competency in technical writing.
- Experience in designing experiments and data analysis.
- Experience documenting experiments in laboratory notebooks
- Working knowledge of biological molecules
- Excellent interpersonal and communication skills that enable effective resolution of project related issues.
Qualifications
- Bachelor’s/Master’s degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field
- Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Vacancy expired!