Formulation Development & Execution - Support formulation experiments for new product development and optimization of existing products.
- Design and prepare prototypes and experimental batches at benchtop, pilot, and scale-up levels.
- Support development of solid oral dosage forms (tablets, capsules, granules).
- Execute formulation activities independently with minimal supervision while escalating complex challenges appropriately.
- Collaborate closely with and support senior R&D team members in daily product development activities.
Process Development & Scale-Up - Support process development, validation, troubleshooting, and technology transfer to manufacturing.
- Execute pilot-scale and scale-up batches to support commercialization.
- Partner with Manufacturing and Engineering teams to optimize processes.
Equipment Operation & Technical Ownership - Set up, operate, clean, and perform changeovers on R&D and pilot-scale equipment, including:
- Tablet presses
- Capsule filling machines
- Coating equipment
- Granulators
- Fluid Bed Dryers (FBDs)
- Ensure equipment is maintained and operated in compliance with SOPs, safety standards, and cGMP requirements.
- Troubleshoot equipment and process issues using strong technical and analytical skills.
Documentation, Compliance & Communication - Maintain accurate and compliant documentation (BMRs, logbooks, protocols, reports).
- Record formulation data, observations, and changes in a timely and clear manner.
- Ensure adherence to cGMP, SOPs, and regulatory requirements.
- Communicate updates, results, and project status effectively to R&D and cross-functional teams.
- Prepare and review technical and customer-facing documents, including:
- Sample shipment cover letters
- Commercial invoices and declaration documents for international shipments
- Tracking and data analysis spreadsheets
Cross-Functional Coordination & Operations - Coordinate with internal departments to support smooth R&D operations:
- QC: Sample drop-off and documentation
- QA: Sample testing, shipment coordination, and results tracking
- Packaging: Sample transfer and packaging
- Warehouse/Inventory: Material availability and tracking
- Purchasing: Requisitions, POs, and delivery timelines
- Maintenance: Equipment and facility repairs
- External Facilities (e.g., VanDyke Building): Raw material transfers
- Request materials through Syspro and ensure availability for trials.
- Schedule and coordinate meetings across R&D and Purchasing teams.
Sample Management, Packaging & Shipping - Package, label, and maintain inventory of samples for:
- Customer evaluations and meetings
- Internal and external testing
- Stability studies
- Ship samples, materials, and documents via FedEx and UPS, including international shipments.
- Prepare all required shipping documentation and ensure compliance with international regulations.
- Coordinate with shipping carriers to resolve delays and ensure timely delivery.
Inventory, Warehouse & Material Management - Maintain organization, labeling, and safety of R&D warehouse and storage areas.
- Ensure proper labeling and storage of raw materials, packaging materials, and supplier samples.
- Manage controlled storage requirements (e.g., probiotics in designated rooms/freezers).
- Track inventory levels, material usage, and delivery timelines.
- Maintain office and lab supply inventory.
Data Tracking & Administrative Support - Packages & labels samples for shipments & customer review.
- Packages all samples for customer meetings & maintains inventory for sample presentation.
- Packages & labels samples for internal & external testing.
- Packages & labels samples occasionally for stability trials.
- Maintains warehouse organization & safety
- Labels raw materials correctly & maintains organization system for each section of the warehouse.
- Labels packaging materials to ensure easy retrieval.
- Labels supplier received raw materials with necessary information for easy retrieval.
- Ensures probiotic samples are correctly stored in R&D probiotic room or freezer.
- Ships samples, materials, & documents via FedEx & UPS
- Ships samples to customers for sample & document review
- Ships samples to external labs for testing along with sample requisitions.
- Ships samples internationally, ensuring all documentation required for other countries is provided.
- Works externally with Fedex/UPS representatives to ensure delayed packages are delivered & documentation is updated correctly.
- Create, Compose, edits, & reviews written material as necessary to share with appropriate internal departments & customers.
- Composes cover letters for customer sample shipments
- Composes required documents for international shipments, such as declaration letters, commercial invoices, & cover letters.
- Creates excel sheets for tracking & comparison purposes.
- Reviews material documents to ensure proper storage.
- Maintains Excel logs for the following:
- Received raw material from 1300.
- Incoming sample raw material from suppliers.
- In-house QC samples for testing & results.
- External lab sample testing & results.
- Samples shipped to customers via FedEx & UPS.
- Creates requisitions through purchasing team & receives Purchase Orders as necessary
- Creates requisitions & receives PO’s through Syspro.
- Monitors purchased materials for all R&D projects & keeps track of all raw material delivery ETA’s
- Reviews invoices for approval for shipping, lab testing, & other external purchases.
- Maintains office supply inventory regularly.
Continuous Improvement & Development - Identify opportunities to improve formulation, processes, and operational efficiency.
- Participate in 5S, safety, and continuous improvement initiatives.
- Demonstrate increasing ownership and decision-making to prepare for advancement.
Additional Responsibilities - Follow all lab safety and PPE requirements.
- Provide guidance and mentorship to junior technicians.
- Perform other duties as assigned to support business objectives.
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Education & Qualification: - Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, or a related scientific field preferred (or equivalent hands-on experience).
- 1–3 years of experience in pharmaceutical R&D formulation, pilot-scale manufacturing, or related technical roles.
- Minimum of three (3) years of work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries.
- Experience with formulation development (e.g., liquids, powders, tablets, gels, capsules, etc., depending on your industry).
- Strong understanding of formulation principles, laboratory techniques, and scientific methods.
- Excellent documentation, organizational, and time-management skills.
- Ability to interpret data, identify trends, and propose scientifically sound conclusions.
- Strong communication and teamwork abilities.
- Proficient with Microsoft Office and lab software (LIMS, ELN, etc., if applicable).
- Hands-on experience with any of the following processes: Blending/Granulation, Tablet Compression and/or Film Coating, Encapsulation, or Pharmacy/Pre-Weigh Dispensing
Certifications, Licenses, Credentials: Skills & Ability - Demonstrates ability to work in a team and assist others.
- Able to follow written instructions precisely and perform basic math calculations as required.
- Understands and is knowledgeable of cGMP, OSHA standards etc.
- Mechanically inclined to understand inner workings of equipment.
- Knowledge of any of the following processes: Blending/Granulation, Tablet Compression and/or Film Coating, Encapsulation, or Pharmacy/Pre-Weigh Dispensing.
- Demonstrates the ability to read and write English in order to be able to understand the industry regulated instruction sheets.
- Has experience with the following: Google Suite, Microsoft Excel, Word, PowerPoint, & Teams, Syspro8
Physical Requirements (lifting, etc.): - Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds.
- Must stand and walk on the production floor for a minimum of 6 hours per shift
- Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.
- Occasionally works from a rolling ladder or step stool, must be to lean over equipment as well as kneeling on the floor to clean under the equipment.
- Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
Work Environment (Office, Warehouse, temperature extremes, etc.): - Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate.
- Employees can be exposed daily to chemicals and cleaning agents.
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