Technical Writing Director jobs in Norwalk, CA

A brief overview

To ensure Bachem can meet the demands of its evolving business and of its diverse customer base, the Director of Technical Operations has been created to support the focus and growth of the business from a technology operations standpoint. The leader of technical operations will ensure that site manufacturing technology is aligned with the overall site strategy and customer needs. The Director of Tech Ops will lead a dedicated team of scientists, chemists, engineers, technical writers, and improvement specialists, focusing on technology transfers from process development to manufacturing, major capital investments, or tech transfers between sites. This role oversees all technical operations activities at the site and reports to the site VP of Manufacturing Operations.

What you will do

• Serve as member of the site leadership team and of the extended science and technology group within the network of sites within the Bachem group.
• Ensure adequate technical support within the organization to late phase clinical products, ongoing commercial manufacturing on 10-100Kgs scale
• Project planning, scheduling, and supporting manufacturing activities as well as special events.
• Lead tech transfer activities as internal site transfers or transfers from client sites to BAM sites.
• Establish and ensure technology requirements are aligned with the site strategy, and that suitable technologies and platform exist to meet future products and processes.
• Coach and develop internal resource capabilities by conducting after-action reviews, proper knowledge management and establishing best practices guidelines.
• Lead and implement efforts to improve on manufacturing efficiencies of clinical/commercial products, troubleshoot manufacturing deviations, lead process change controls, implementing associated CAPAs and evaluation of CAPA’s effectiveness.
• Partner with all other stakeholders organization including Supply Chain, Quality Control, Quality Assurance, Procurement, Production, Service/Facility, Engineering, and Project Management to develop long-term strategy that may lead to COGs improvement, developing risk portfolio management, and aligning on tech transfers best practices across the network.
• Work closely with all departments, and other sites in developing an established checklist for proper tech transfer activities intra-site, but also inter-sites within the network.
• Support ongoing proactive process analysis (PPA) tools to proactively monitor health of commercial processes and develop controls to enable robust manufacturing.
• Stay abreast of industry trends within the peptide and oligonucleotide fields to ensure adherence to the latest science and technology standards.
• Serve as primary point of contact for the risk assessment tool that manages end-to-end risk to the manufacturing operations and actively engage in frequent GEMBA walks, to identify and manage risks.
• Provide regulatory compliance support during regulatory inspections; provide oversight for scale-up, support pre-approval inspection, providing data to support design space, normal operating ranges of a new process and execution of process performance qualification.
• Maintain state-of-the-art work environment by promoting cleanliness and educating direct reports on the importance of proper use and maintenance of equipment

Qualifications

• PhD or master’s degree in chemical, biochemical engineering, pharmaceutical sciences, or any other chemistry or engineering related field
• 10 years of experience in process development, manufacturing, or operations
• 3 - 5 years of leadership experience, preferably of cross-functional teams
• Strong knowledge of GMP and regulatory frameworks.
• Demonstrated decision making, analytical and problem-solving skills. Familiar with Lean Six Sigma and their applications to manufacturing.
• Proven skills to manage a large number of people with diverse functional backgrounds.
• Strong project management skills and ability to communicate effectively upward within the organization, but also to external stakeholders.
• Good understanding of business financial management to support business case developments and budget planning.
• Proven skills in working and collaborating across multiple sites.
• Proven ability to develop a High Performing Team and integrating new technologies for operational excellence.
• Familiarity with scientific systems and procedures - technical understanding of the manufacturing process and equipment

Base Salary Range: $126,000 - $165,000

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status