PURPOSE 

Primary role is to perform chemical analysis of pharmaceutical products and routine laboratory operations in a cGMP environment.

REPORTS TO

Reports to the Quality Control Manager.  Internal relationships include Manufacturing, Research & Development, Analytical Development and Quality Assurance.

DUTIES AND RESPONSIBILITIES

• Conducts routine analysis of raw materials, in-process and finished Drug Substance and Drug Product according to Standard Operating Procedures (SOPs), cGMPs and cGLPs
• Performs incoming visual inspections of raw materials and initiates records for receipt
• Conducts and reviews routine and non-routine analysis of raw materials, in-process materials, Drug Products (API), and Finished Drug Substances and Drug Products according to Standard Operating Procedures (SOPs), cGMPs and cGLPs
• May conduct testing using HPLC, GC, FTIR, UV-Vis and wet chemistry methods under supervision
• Compiles data for documentation of test procedures and prepares reports
• Calibrates and maintains lab equipment.  Proactively ensure equipment is calibrated and maintained to minimize disruption to production schedules.
• Administers quality control systems according to cGMP and FDA guidelines
• Write and Revise Standard Operating Procedures SOPs
• Ensures proper cGMP/cGLP documentation and maintenance of quality records
• Participate in method validation and transfer activities

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Must have a bachelor’s degree in a science discipline (Chemistry or pharmaceutical preferred) with at least 3-4 year hands-on laboratory experience in FDA regulated industry or associate degree with 7-10 years of hands-on laboratory experience in GMP environment, or equivalent.
• Strong background in principles of separation using analytical instrumentation such as HPLC, GC, UV/VIS in a GMP environment.
• Expert knowledge of ICH and FDA guidelines
• Expertise in Chromatographic Data Acquisition and LIMS Systems experience such as ChemStation or Empower 3
• Attention to details in collecting data and accurately maintaining laboratory notebooks required
• Drug Screen and DEA Background check required

WORKING CONDITIONS / PHYSICAL REQUIREMENTS  

• Must be able to conduct visual inspections of incoming materials to verify appearance and printed content (e.g. product labels) meet product specifications
• Must accurately distinguish different colors for reporting of appearance and colorimetric tests
• Occasional lifting of up to 50 lbs

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor employment Visas at this time.

PURPOSE

Primary role is to perform Research & Development and Process Development duties to support API development, production and business goals. Develops new processes and products.

REPORTS TO

Reports to the Vice President of Research & Development. Interacts with various business units often, including non-technical personnel. This position works independently and in a team environment.

DUTIES AND RESPONSIBILITIES

• Provides technical expertise in all facets of API process development and research and development activities.
• Develops, plans, and executes experiments independently and communicates results to various stake holders and external entities including non-technical personnel.
• Subject matter expert in the field, keeps abreast of the latest research, literature, and new frontiers in the industry.
• Informs management of chemical and business opportunities as research progresses.
• Responsible for process oversight, identifying outlier trends, root cause analysis, and oversees corrective action implementation.
• Maintains research lab, documents, and materials compliant with all applicable regulation (FDA and DEA).
• Prepare weekly updates and submit them to clients. Participate in weekly calls with a client and provide project progress updates.
• Assures a safe and productive laboratory environment.
• Mentors and supervises junior chemists.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Must be detail oriented, self-motivated, can multi-task in a production environment and be capable of planning daily activities to achieve short-term and long-term objectives in a quality, regulated environment.
• Must be able to work independently within a multidisciplinary team as well as plan, execute, and communicate results of experiments, often to non-technical clients.
• Must be flexible with schedule as projects dictate.
• Minimum of a master’s degree in chemistry or related field with emphasis and experience in Organic Chemistry and at least 5 years relevant work experience. Ph.D in synthetic organic chemistry with 2 years relevant work experience is preferred. Experience in cannabinoid and psychedelics science is a plus.
• Experience with cGMP operations preferred.
• Mastery of written and verbal English communication skills required.
• Drug Screen and DEA Background check required.

WORKING CONDITIONS/ PHYSICAL REQUIREMENTS

Must have no physical limitations that would prevent:

• Able to periodically lift 50 pounds or more
• Able to climb a ladder
• Able to wear a full-face respirator

The worker will be required to handle controlled substances and work in the presence of hazardous materials with appropriate PPE, including those that are:

• Flammable / explosive
• Carcinogenic
• Oxidizing agents
• Respiratory hazards
• Highly acidic / basic
• Under high pressure
• At high temperature
• Halogenated solvents
• Organic materials

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor employment Visas at this time.

PURPOSE

Material Handler will be entrusted with the comprehensive management of the receiving process, encompassing the initial receipt of materials through to their final release. The role involves close collaboration with the production team to ensure that all production requirements are met promptly and efficiently. The role is responsible for staging materials for each production run, maintaining an accurate and current inventory of all materials and reconciling production and material records to always ensure precision and reliability.

The role is responsible for regular shipping to laboratories, clients, and handling controlled substances. The role will assist and provide support with international shipments and waste shipments, ensuring compliance with all relevant regulations and standards.

REPORTS TO

The position reports to the Warehouse Inventory Manager and provides support to maintain receipt of incoming raw materials, quality control sampling, cGMP warehouse storage, raw material issuance/reconciliation, finished product shipping and inventory control via internal GMP systems. This position supports API and finished product manufacturing, quality control, EHS, warehouse management and accounting for inventory control.

DUTIES AND RESPONSIBILITIES

• Oversee all delivery processes to ensure efficiency and accuracy.
• Receive, inspect, and store materials, supplies, and equipment in an organized and efficient manner.
• Segregate GMP materials from non-GMP materials.
• Ensure all materials are fully received, appropriately labeled (quarantine, release, etc.), and stored in the correct locations. This GMP process requires the accurate completion of certificates, forms, and logs for each material received for production.
• Transport materials and supplies to and from storage areas, loading docks, and production areas using various types of equipment, such as forklifts, hand trucks, or other material handling equipment.
• Handle and maintain controlled substances in compliance with regulations.
• Monitor inventory levels of raw materials and finished goods, maintaining accurate records of inventory levels, transactions, and forms.
• Collaborate effectively with the production team to meet production needs in a timely manner.
• Perform weekly warehouse cleaning duties and maintain a safe and clean work environment by keeping work areas free of debris and hazards.
• Conduct weekly equipment inspections to ensure all equipment is properly maintained and used safely and efficiently.
• Perform weekly solvent cycle counts.
• Conduct monthly expiry reports, warehouse inspections, and EHS (Environmental, Health, and Safety) inspections to identify discrepancies, maintain accuracy, and aid in the ordering of materials.
• Manage regular shipping to laboratories and clients.
• Assist and provide support with international shipments, ensuring compliance with all relevant regulations and standards.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• High School diploma or GED equivalent.
• Associate’s degree is preferred.
• Experience in an FDA/cGMP and/or a DEA regulated environment is highly desired.
• Must have strong written verbal communication skills.
• Must be able to use computer technology, i.e., Microsoft Office.
• Demonstrate sound work ethics, dependable and flexible.
• Able to wear a respirator.
• Drug Screen and DEA Background check required.

WORKING CONDITIONS/ PHYSICAL REQUIREMENTS

• Standard office environment.
• The ability to bend, squat, and lift up to 50 lbs.
• Must be able to work on a computer.

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor employment Visas at this time.