Research Scientist II; Small Scale Manufacturing

The Research Scientist II's principal responsibility is to manufacture batches of intermediates and APIs under cGMP protocols.

We proudly offer

• Generous benefit options (eligible first day of employment)

• Paid training, vacation and holidays (vacation accrual begins on first day of employment)

• Career advancement opportunities

• Education reimbursement

• 401k program

• Learning platform

• And more!

Essential Duties and Responsibilities

• Adapt internal or customer supplied procedures to cGMP production operations

• Demonstrate proficiency in synthesizing known compounds efficiently using in-house batch record procedures on a multi-kilogram scale

• Perform thorough cleaning and sanitization of all manufacturing spaces prior to commissioning for use.

• Manage all aspects of a cGMP manufacturing campaign, including batch record review, safety evaluations, material procurement, equipment ordering/set up/cleaning and execution of the chemical operations.

• Assist colleagues with execution of projects, even when not directly assigned

• Assist in troubleshooting activities including running additional experiments, data mining, or literature searches.

• Maintain familiarity with all cGMP SOPs and ensure compliance during production

• Ensure that all equipment is operated according to SOPs and assist others in this aspect as necessary

• Maintain familiarity with the Chemical Hygiene Plan. Follow responsible actions regarding chemical disposal.

• Conduct laboratory operations in a safe manner. Exhibit safety awareness and safe work practices. Learn the particular hazards associated with all chemical processes that are assigned and take the appropriate precautions to setup equipment properly and execute all operations safely.

• Supervise and train RS1 and/or production or mechanical technicians, as appropriate

• Write interim and final production reports as required

• Routinely communicate and present the status of the assigned programs and potential problems/solutions

• Coordinate production schedule with other departments including Quality Assurance, Analytical services, and Chemical development.

• Perform investigations, documentation, and closure of all quality events related to production.

• Review documentation according to thoroughness, scientific correctness, and cGMP compliance.

• Assist in scheduling regular maintenance for all equipment to ensure that it is maintained according to SOPs including calibrations and any preventative maintenance needed

• Represent the organization in providing answers to questions related to scale-up knowledge, cGMP procedures, and Curia policies

• Maintain knowledge of previously executed programs to serve as subject matter expert when processes are then transferred to other Curia production facilities. Attend regular meetings for these programs and answer questions related to production and results.

• Manage workload and time to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.

• Recommend and implement methods to continually improve and increase the quality of products and/or service

Supervisory Responsibilities

This role has a potential to supervise research scientists, and/or mechanical or production technicians.

Education and Experience

• Bachelor's in chemistry or related with two years of experience; or

• Master's degree in related experience.

Knowledge, Skills and Abilities

• Chemical Hygiene training

• Ability to read, analyze and interpret common scientific and technical journals, internally generated reports and procedures, financial reports and legal documents

• Ability to read and comply with internally generated SOPs for cGMP compliance

• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community

• Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems

• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases

• Ability to understand a mechanical system in regards to execution of chemistry using standard kilo lab glassware, reactors, and equipment.

• Ability to use office suite to schedule meetings, organize data, and author and issue reports to management and customers

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, use hands to handle or feel; talk and hear. The employee frequently is required to reach with hands and arms. The employee is required to stand, walk, climb or balance, and stoop, kneel, crouch and crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.

Work Environment

While performing the duties of this job, the employee is routinely exposed to moving mechanical parts and hazardous chemicals. The noise level in the work environment is usually moderately loud.

Salary: 67,000- K per year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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