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Director Of Process Development Jobs in Wisconsin

Wisconsin

Director of Dev/Ops

Madison, WI

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Director Of Process Development information

What are the key skills and qualifications needed to thrive as a Director Of Process Development, and why are they important?

To thrive as a Director Of Process Development, a strong background in process engineering, project management, and a relevant advanced degree (such as in chemical engineering or biotechnology) is essential. Expertise in process simulation software, Six Sigma/Lean methodologies, and regulatory compliance systems is typically required. Leadership, strategic thinking, and effective cross-functional communication are vital soft skills for driving innovation and aligning teams. These competencies ensure successful process optimization, regulatory adherence, and achievement of organizational goals in a dynamic industry.

What does a Director of Process Development do?

A Director of Process Development oversees the design, optimization, and implementation of processes within an organization, often in manufacturing, biotechnology, or pharmaceuticals. They lead teams to improve efficiency, ensure quality standards, and drive innovation from concept to production scale. This role involves collaborating with cross-functional departments, managing budgets and timelines, and staying updated on industry trends and regulatory requirements. Their ultimate goal is to streamline operations and support the company's strategic objectives.

What is the difference between Director Of Process Development vs Process Engineer?

AspectDirector Of Process DevelopmentProcess Engineer
CredentialsBachelor's/Master's in Engineering, often with experience in process developmentBachelor's or higher in Engineering or related field
Work EnvironmentLeadership role overseeing process development teams, strategic planningHands-on technical role focusing on process design and optimization
Industry UsageCommon in manufacturing, pharmaceuticals, biotechFound across similar industries, often reporting to Directors or Managers

The main difference is that the Director Of Process Development leads and strategizes process development initiatives, while Process Engineers focus on executing technical process improvements. The director role involves higher-level planning and team management, whereas Process Engineers are more involved in technical implementation.

How does a Director of Process Development typically collaborate with cross-functional teams to drive process improvements?

A Director of Process Development regularly partners with R&D, manufacturing, quality assurance, and regulatory teams to develop and refine processes. This collaboration involves leading cross-functional meetings, aligning project goals, and ensuring that new or improved processes meet both technical and compliance standards. Effective communication and project management skills are essential, as the director often serves as a bridge between technical staff and executive leadership, ensuring that process initiatives support broader business objectives.
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Director Of Process Development jobs near you
Senior Scientist I, CMC Process Development

Senior Scientist I, CMC Process Development

Arrowhead Pharmaceuticals

Verona, WI • On-site

$115K - $140K/yr

Full-time

Posted 4 days ago

New

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
A Senior Scientist I, Late Phase Process Development works within the CMC department on small molecule and conjugation chemistry to generate knowledge and documents to support late phase process development and regulatory filings.
Responsibilities
  • Oversee and perform experiments for late phase process development of API and regulated materials, including process improvement, impurity identification, and fate and purge studies
  • Analyze and interpret experimental technical data
  • Work with internal and external teams to manage the determination, supply, and specifications of regulated materials
  • Maintain knowledge of process and project history as well as process development and regulatory issues
  • Collaborate with Regulatory Affairs in the preparation of regulatory documents, including CTAs, IMPDs, NDAs, and MAAs.
  • Make oral presentations to scientists and management
  • Guide, mentor and develop chemists across the team
  • Support talent acquisition efforts
  • Identify growth opportunities for team members to reach their full potential
  • Work closely with other department members
  • Recommend new ideas, synthetic routes, and technologies to support departmental goals

Requirements
  • PhD in Chemistry or related field with 2 years of industry experience; Master's Degree in Chemistry with at least 8 years work experience; or a Bachelor's Degree in Chemistry with 10 years equivalent industry work experience
  • Excellent verbal and written communication skills
  • Excellent problem-solving skills
  • Knowledge in synthetic chemistry and analytical technology, hands-on experience in syntheses and development of small molecule and large molecule drug candidates

Preferred
  • Strong track record of scientific publication
  • Prior experience with cGMP manufacturing and pharmaceutical regulatory compliance
  • Prior experience working with or within CDMOs

Wisconsin pay range
$115,000-$140,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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