Process Development Manager - Therapeutic Oligonucleotide

The Therapeutic Oligonucleotide Process Development Manger is responsible for leading a team of PD scientists/chemists, providing process development support to the Therapeutic GMP Oligonucleotide production capability at LGC Biosearch. Operating out of our Petaluma, CA. site, this position will include working with Analytical, Quality Assurance, as well as colleagues in Germany to continue expanding LGC Therapeutic Oligonucleotide landscape.

Areas of Responsibility:

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

Essential Functions:

• Provide technical mentorship and direction to PD scientists/chemists
• Ensure that PD group is properly staffed and trained
• Provide technical support to manufacture group on staff training and quality event investigation
• Ensure comprehensive training plans are developed and followed for Therapeutic Oligonucleotide team members
• Serve as a technical contact for key Therapeutic Oligonucleotide customers and participate in client audits, visits and conference calls
• Write and review manufacturing procedures and documentation used in the Therapeutic Oligonucleotide labs
• Contribute to NAC and NAT business to evaluate new business opportunities
• Provide input on site continuous improvement efforts

Skills, Abilities, and Competencies:

• Strong team leadership and group management skills
• Must be a good team builder, who can effectively grow the organisation to meet business needs
• Able to multitask work in a fast paced environment
• Possess a strong attention to detail and a methodical approach to tasks
• Strong communication and problem solving abilities are necessary

Education/Experience/Licenses/Certifications:

• A PhD in Chemistry or related discipline with 3+ years of industry experience directly related to therapeutic oligonucleotide contract manufacturing
• Demonstrated proficiency in the process development, process transfer, scale up/down modelling, equipment and methods utilised in the GMP manufacturing process
• Demonstrated experience working with common and unique therapeutic oligonucleotide modalities
• Experience working in a GMP environment and providing regulatory support to customers developing oligonucleotide based therapeutics
• Previous management and people leadership experience are required

Technology/Equipment Skills:

• Microsoft Office, Outlook, Word, and Excel
• Use of a web browser
• Proficiency with GE Unicorn or similar software is required