Katecho Formulation Chemist in Des Moines, Iowa
+ + Job Tracking ID: 512885-693197
Job Location: Des Moines, IA
Job Level: Mid Career (2+ years)
Level of Education: Masters Degree
- Job Type: Full-Time/Regular
Date Updated: July 12, 2019
Years of Experience: 2 - 5 Years
Starting Date: July 23, 2019
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Design Engineer Manager
Under the Direction of the Design Engineer Manager, this position will be responsible for developing topical/transdermal products (patches, lotions, creams, ointments, gels, etc.) working collaboratively with the customer, internal design and manufacturing teams to successfully roll-out products. Ultimately responsible for carrying out and overseeing formulation development and stability testing of products throughout the manufacturing process.
PRIMARY DUTIES AND RESPONSIBILITIES
Serves as team representative and subject matter expert in topical/transdermal product (patches, lotions, creams, ointments, gels, etc.) development for medical device hydrogels, drug products and personal care products. Performs research activities in the development of topical/transdermal products from conception to manufacturing. Develops formula prototypes, batch IDs and coordinate end products for lab analysis.
Performs hands-on process/product scale-up studies and designs/executes DOE studies on products.
Prepares, reviews and/or approves written documents to support technical projects, regulatory submissions and validation projects.
Executes process validation batches in collaboration with the production team. Assists in writing and executing formulation and development plans, study reports and technology transfer documents.
Prepares documentation and trial strategies leading to regulatory submission testing and to consumer trials.
Researches equipment used for the development, lab testing and manufacturing of the products. Works with equipment design team to incorporate new processes into existing equipment or to design new equipment.
Maintains lab notebook to document processes and provide records of results.
Operates basic lab equipment, including mixers and coating machines with a minimal amount of supervision.
Creates SOPs, APRs, Formulation Change Controls, CAPAs, investigations deviations and creates master batch records for the manufacturing process.
Leads the activities to develop and create packaging solutions to ensure the integrity of the product throughout the shipping and expected shelf-life.
Works with customers to create and develop documentation to support product efficacy, dosage and safety rationales, correct usage and active ingredients listing.
Ensures adherence and compliance to FDA cGMPs for medical devices, pharmaceutical drugs and personal care products and other global regulations.
Continuously refines processes that will speed the product development process and provide continuous improvements to product quality.
Other duties and responsibilities may be assigned as required.
Request necessary supplies and resources required to complete the jobs assigned.
Solve and communicate problems with materials, tools, fixtures, machinery, etc.
Suggest improved or alternate methods of producing product.
Must complete a Non-Compete Agreement and Patent Agreement.
Experience and Skills:
MS in Chemistry or Chemical Engineering or related field. PhD preferred.
3-5 years’ experience in related product development/formulation field. Pharmaceutical preferred.
Preferred experience developing and utilizing analytical methods for drug product testing
Comfortable working in a start-up environment.
Highly motivated and able to work independently and in a collaborative team environment.
Strong project management skills; detail orientation and able to manage and organize numerous projects.
Able to communicate and work with others as a team, utilizing strong leadership skills.
Working understanding of 21 CFR Part 210 and 211 and 820, along with other relevant cGMP regulations.
Good work attendance and dependability.
Strong computer skills in MS Office environment.
Must be able to pass a background check.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. The employee is occasionally required to use hands or fingers to handle objects, reach with hands and arms, stoop, and frequently lift and/or move up to 25 pounds. The employee must be able to communicate with speech and hearing. Specific vision abilities required by this job include close vision, distance vision, and color determination.
The employee must be able to work with the chemicals and drug formulas as part of the design and manufacture process. The job requires use of respirator; must pass the physical requirement and be fit tested for respirator.
Equal parts working in lab, manufacturing areas and office. Must be able to wear protective gear (gown, hair/beard nets, gloves, goggles, masks, etc.). Must be able to follow gowning/garbing procedures.
PPO/HMO Health, Dental, Vision, FSA, Life options, LTD/STD options, 401(k), PTO