CPG Scientist I

LGC Genomics locations Petaluma and Novato, CA, as well as our sister site in Denmark, represent a focused, collaborative culture of producing mission-critical genomics components, primarily oligonucleotides and supporting reagents, for our diverse customer base. We believe in Science for a Safer World and have embodied our mission by supporting first responders during the COVID-19 pandemic where our Biosearch Technologies portfolio has been and continues to be enabling millions of PCR tests worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization.

Position Summary:

This position requires a talented and self-managing individual to work closely with members of Process Development, CPG Manufacturing, Commercial Sales, Global Nucleic Acid Chemistry, and Research and Development groups with the objective of providing robust and efficient processes for solid supports for DNA/RNA synthesis. This role uses expert knowledge of solid supports for DNA/RNA synthesis, manufacturing processes, and chemistry to ensure the optimized and consistent manufacture of high quality supports for DNA/RNA synthesis in alignment with customer and company goals/guidelines, to support investigations, and participate in improvement initiatives within manufacturing operations (including scale-up). This position will also work directly with production personnel to achieve increased throughput, yields, and efficiency of new and existing manufacturing processes and instruments. This role is responsible for scoping, planning, and execution of development projects pertaining to: all types of solids supports for DNA/RNA synthesis, existing or new manufacturing methods/products, and improving the resulting DNA/RNA synthesis quality of existing supports. The ideal candidate will be able to gather requirements from stakeholders in the necessary areas, develop robust processes, and transfer those processes to manufacturing groups. This position requires an individual that is self-motivated, thinks independently, demonstrates curiosity, and is passionate toward their work. This person may be called upon to assist other groups such as Production, Research and Development, and Process Development as needed. This includes interacting with customers or the commercial team when necessary, providing comprehensive research proposals, organizing resources including staff and equipment, managing reagents, writing and validating protocols and reports, and working across disciplines to assure successful execution of assigned projects. The role will include assessing daily production priorities along with development tasks, reporting workload and priorities to area supervisors and management, and performing production processes as necessary.

Areas of Responsibility:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily.

Essential Functions:

Equipment:

• Effectively communicate with supervisor to ensure all equipment is functional and available for use.
• Scope project needs and propose/justify any new equipment needed to support work (including generating CAPEX IA’s as needed).
• Where needed, coordinate with internal teams and external vendors to ensure:

• Equipment is properly commissioned, maintained and repaired.
• Ensure new and existing instruments and processes are properly evaluated for process repeatability that results in higher production yields.

Process:

• Responsible for the generation of specialized CPG protocols.

• Develop, maintain, and revise the processes and documentation that allows for the efficient repeatable manufacture of solid supports for DNA/RNA synthesis.
• Ensures that all procedures and resources in the production process are compliant with ISO 9001:2008
• Develop processes and procedures for new customer driven production requirements.

• Develop production line flow utilizing Lean manufacturing principles.
• Develop procedures for newly developed or re-worked compounds with the ultimate goal of process transfer to the CPG production technicians, or when necessary to an external manufacturing facilities.
• As needed, generate TSR (technical summary reports) to justify process changes and improvements.

Project:

• Assumes project management responsibilities for CPG special projects including: Scale-up, optimization studies, process transfers, and new product implementations. Project reporting to be established and appropriate project updates provided as necessary until project completion and subsequent hand-off.
• Provide clear and detailed development plans including goals, timelines, and tangible
• Gather stakeholder requirements, develop clear project goals, execute development experiments, verify results and draft qualification and continued verification documents.

Knowledge base:

• Maintain an up-to-date knowledge of current and past literature related to solid supports for DNA synthesis, oligonucleotide synthesis, and analytical methods.
• Demonstrate working knowledge of all production scale processes and provide input for process optimization and scale up.
• Learn and understand common process development tools and incorporate them into projects.
• Assist in the transfer of small to mid-scale production to full-scale production by providing adequate documentation, training, and assistance to the custom oligo production group and/or others involved in production.
• Maintain a working knowledge of all production scale processes and provide input for process improvements and optimization.
• Learn and understand common process development tools and validation techniques and incorporate into development projects to minimize transfer time and production failures.

Team Support:

• Assist with the training of Tech I’s and II’s, and provide assistance to associates relating to CPG manufacturing when needed.
• Mentor staff of all level, working closely with various group members to assure successful process and methods transfer.
• Effectively communicate and coordinate with Chemical Production team members, affected employees in other departments, and the CPG Production Manager to assure the most efficient use of time and resources.

Production Tasks:

• Perform assigned tasks using the established protocols and methods on the appropriate equipment and within the given final specifications and timeline.
• Demonstrate a working knowledge of all manufacturing steps by operating independently when needed, and being able to analyze and problem solve failures/ out of spec instances.
• Continuously replenish inventory of CPG products as assigned by CPG Manufacturing Lead, Supervisor, or Manager.
• Demonstrate operational capability of setting-up, troubleshooting, and running large scale synthesis safely (up to 100L).
• As needed, ensure the availability of raw materials and equipment to complete tasks in a timely manner that complies with internal and external customer requirements.
• Assist with the synthesis of CPG reagents and starting materials as needed.
• Make recommendations to supervisor as necessary regarding resources required to meet objectives and timelines, including materials, equipment, employee assistance, and work space.

Policies:

• Maintain a safe, organized, and clean work space.
• Comply with all company, departmental, and regulatory policies.
• Participate in deviation reporting and process optimization of protocols.

Other Skills and Abilities:

• Excellent understanding of laboratory safety, chemical safety, and general safety practices in a manufacturing environment.
• Excellent team-player with the ability to operate independently.
• Competent with chemical calculations for molarity, density, and use of the metric system.
• Strong attention to detail.
• Strong time management skills.
• Excellent verbal and written communication skills.
• Multi-tasker.

• Technical proficiency that enables effective management of the production support and development process.
• Proven project management skills.
• Ability to communicate effectively and self-manage daily tasks.
• Use of a QbD approach, including goal definition, DOE, risk assessment and process control implementation is preferred.
• Proficiency in statistics software such as JMP or Minitab is preferred.
• Familiarity with modern DNA synthesis, purification and analytical platforms is preferred.
• Experience with cGMP, FDA regulatory requirements, and U.S. Pharmacopeia Convention (USP) practices preferred but not essential.

Education/Experience:

• B.S. in Chemistry (or related field) with 5 years of relevant experience or an M.S with 3 years of relevant experience.
• Familiarity with analytical techniques such as LC/MS, HPLC, NMR, KF, etc.
• Experience in CPG production, optimization, and scale-up in a development setting.

Computer Skills:

Microsoft Office, Outlook, Word, and Excel. Use of a web browser. Familiarity with MES/ERP systems and Chemdraw preferred but not required.

Working Conditions:

Physical Requirements:

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.

INTERMITTENT: Less than 15% of the time in a typical week

OCCASIONAL: 15% to 45% of the time in a typical week

FREQUENT: 45% to 70% of the time in a typical week

CONTINUOUS: Over 70% of the time in a typical week

For each physical requirement and/or working condition that is applicable to the job, place an “x” in the column that best represents the amount of time spent.

Protective clothing or equipment required. (For example, steel-toe shoes, hearing or eye protection, etc.)

• Adhere to company PPE policy

Hazardous or caustic materials

• Frequent handling of hazardous or caustic chemicals.

Describe the types of injuries or illnesses that employees may be subject to and that cannot effectively be removed from this job, despite efforts to mitigate risks.

• Repetitive motion injuries to hands, wrists, arms.
• Cuts due to glass breakage

Essential competencies and behaviors: Resonates and operates in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect