Job Specifications
Payrate: $26.50 - $27.50/hr.
Summary:
This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecules, RNA, virus). Additionally, the position works on ways to improve how data is analyzed and the use of statistical models to inform decisions throughout drug product development. The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.
Responsibilities:
Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
Work independently, taking ownership of projects and self-manage work packages with appropriate communication and partner concern.
Plan, design, execute and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management.
Apply basic science/engineering skills and first principal modeling to solve technical problems
Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as supporting commercial products in lifecycle management
Perform data analysis using advanced statistical/analytical techniques with proficiency in statistical analysis software
Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
Deliver progress reports and presentations to ensure management awareness and engagement of the status, advancement, and future program functional needs
Ability to travel domestically and internationally up to 10% of the time
Preferred Qualifications:
Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related discipline.
2+ years of relevant lab experience.
Understanding of physical/chemical stability of proteins.
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with procedures and policies.
Proficient computer skills.
Self-motivation, adaptability and a positive attitude.
Critical thinking, problem solving, and independent research skills.
Good organizational skills with strong attention to detail.
Excellent communication (oral and written).
Must Have Skill:
Lab Experience: Hands-on experience in a laboratory setting is crucial. This includes familiarity with lab equipment, techniques, and safety protocols.
Work in a Team: The ability to collaborate and work well within a team is essential. This involves effective communication, cooperation, and the ability to contribute to group projects.
Communication: This includes drafting technical reports, presenting study objectives and results, and facilitating discussions.
Basic Qualifications:
Master’s degree or bachelor’s degree and 2 years of scientific experience or associate’s degree and 4 years of scientific experience Or High school diploma / GED and 6 years of scientific experience
Pay Transparency: The typical base pay for this role across the U.S. is: $26.50 - $27.50 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the