Job Description
Formulations Research Scientist
Alabaster, Alabama
Vacancy 4470 Be part of our journey As a world leader in pharmaceutical excipients, vaccine adjuvants and lipid delivery systems for human and veterinary applications, Avanti Polar Lipid's technological expertise and commitment to innovative drug delivery solutions goes beyond standard requirements to help develop world-leading pharmaceutical and biologic products.
Position Summary:
Goal-driven and project-focused with ability to plan experiments, produce formulations, characterize final product and analyze data output.Performs laboratory and analytical techniques independently.Works well in a fast-paced scientific environment.Can assist in formulation and process development, scale-up and optimization, and troubleshooting.
Ensures formulations laboratory and GMP areas in high state of inspection preparedness and safety compliance.Performs routine facility and general equipment upkeep.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities : include the following. Other duties may be assigned.
- Draft, review, and execute formulations protocols
- Perform literature searches and summarize information accordingly related to customer requests, technical support inquiries, and marketing initiatives
- Produce research-grade and GMP-grade liposomal and LNP formulations using a variety of different techniques including, but not limited to, homogenization, extrusion, microfluidics, dialysis and TFF
- Operate formulations equipment as directed, in a safe manner, and following all applicable SOPs
- Calibrate/clean/maintain formulations equipment
- Assist in training, direction and development of technicians and entry level associate scientists
- Maintain a basic understanding of cGMP compliance
- Accurately follow applicable procedures and policies
- Support sales, marketing, business development with lipid technology understandings
- Communicate with and support customers through email, video calls, conferences, and symposia
- Perform basic analytical techniques related to formulations, and assist in determining appropriate analytical testing and specifications
- Adhere to all applicable regulations, policies, and procedures for health, safety, security and environmental compliance as outlined in the company's policies and SOPs
- Assist in creating and updating SOPs, BPRs and other required documentation
- Contribute to corrective and preventive action proposals
- Participate in routine cleaning/maintenance of the research and cGMP laboratories
Supervisory Responsibilities: This position does not have supervisory responsibilities.
Education and/or Experience :
Bachelor's degree in scientific discipline and 8+ years experience in pharmaceutical laboratory or manufacturing environment, Master's degree in scientific discipline and 4+ years experience, or Ph.D. in scientific discipline.Previous lipid handling and drug delivery experience preferred.Knowledge of microfluidics, dialysis and TFF processing required; Dolomite-specific experience a plus.
Certificates, Licenses, Registrations: None
Skills and Abilities: - Proficiency in wet bench techniques and experiments
- Safe handling of flammable solvents, volatile solvents, HPAPIs, strong acids and bases
- Ability to apply theoretical knowledge and experience to problem solve
- Strong attention to detail
- Ability to keep work environment neat and free of clutter
- High level of integrity and reliability
- Intermediate math skills, good handwriting skills required
- Intermediate mechanical skills required for manipulation of manufacturing equipment, such as glassware, tools, power equipment, balances, gas cylinders, ovens and vacuum systems.
- Ability to work under deadlines with general guidance
- Good understanding of cross functional collaboration
- Ability to work both in a team environment and work independently
- Ability to align personnel/department schedule with production schedule
- Proficient in basic computer applications and software and ability to learn new programs as needed
Other Qualifications: Physical Demands:
While performing the duties of this job, the employee is regularly required to talk, give oral instructions; listen and hear instructions, customer and/or employee responses, etc. The position is active and requires standing, walking, bending, kneeling and stooping regularly. The employee must occasionally lift and/or move items up to 50 pounds, and assist in moving equipment in excess of 100 pounds.Requires frequent use of fine manipulation.
Work Environment:
Requires the ability to gown and wear all appropriate personal protective equipment.Employees must meet hygiene and health requirements to allow them to work in a cGMP environment.The job function routinely works with chemicals, organic solvents, biological samples, and caustic chemicals.
This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position. While this is intended to be an accurate reflection of the current job, Avanti Polar Lipids, Inc. reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g., emergencies, change in workload or technology developments).
Avanti/Croda recognizes employees as our strength and the diversity they bring to our workforce are directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including age, race, color, religion, national origin, gender, sexual orientation, gender identity, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.
Equal Opportunity Employer/Disability/Veterans.This Organization Participates in E-Verify. Croda
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