Job description
Are you looking for a company with a strong culture and collaborative team?
This client is an industry leader, providing innovative life science solutions. This role is part of a team that consists of innovative professionals with diverse skillsets. They work together in achieving the goal to safely manufacture high-quality materials used in the client’s products that serve a variety of global customers. This position will be a key member focusing on the new business area of Active Pharmaceutical Ingredients (API).
This position will work closely with Custom customers supporting their drug development activities internally and with outside contractors. Additionally, this position will work with Engineering to develop in-house drug product development capabilities focused initially on capsulation.
CORE DUTIES:
- Drive multiple drug product development programs in conjunction with cross-functional project teams. The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications in the USA, Europe, and other global markets.
- Define, align scientific and regulatory strategy, manage, and execute drug product programs utilizing both external vendors and internal capabilities.
- Work with external partners including CROs and CMOs and regulatory agencies.
- Author and review technical documents in support of regulatory submittals and preparation of submission ready sections. Manage input with internal team of individuals, consultants, and SME’s as part of regulatory submission process.
- Oversee CROs and CMOs as a technical expert and coordinate contract work to ensure projects adhere to established timelines and technical specifications.
- Facilitate API and finished drug product (dosage form) development activities including biochemical and biophysical characterization, formulation development, and extractable/ leachable studies, etc.
- Prepare presentations, organize meetings, and collaborate with other scientists and departments.
- Identify issues that may delay timely completion of critical project tasks and escalate as needed.
- Work cross-functionally and communicate effectively across functional areas and collaborate across the organization to help identify/develop new external development capabilities.
- Lead projects/programs managed by the Product Launch and Change Planning (PLCP) function.
- Provide understanding of cGMP and global regulatory requirements for drug product development and manufacturing.
- Manage and resolve conflict within the project team. Lead cross-functional teams within Process Development across all modalities and across all commercialization stages as needed. Facilitate and incorporate lessons learned and standard methodologies.
- Draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions.
- Play a critical role in the resource/financial management and forecasting of individual projects on an ongoing basis.
- Demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvements.
- Apply project management best practices in the initiation, planning, execution, control and closing of projects.
- Perform other duties as assigned.
- Demonstrate inclusion through their own words and actions and is accountable for a safe workspace. Act with kindness, curiosity, and respect for others.
- Embrace and are open to incorporating the company’s core principles in daily work.
- Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
KEY QUALIFICATIONS:
- Degree in pharmaceutical sciences, chemistry, chemical engineering, biology, or related sciences.
- Minimum 10+ years industrial experience in a pharmaceutical setting with specific focus on drug product development.
- Experience with methods for the biochemical and biophysical characterization of small and large molecules and dosage forms of various nature, including capsule and IM.
- Excellent technical written and oral communication skills.
- Good organizational skills and ability to meet challenging project deadlines among competing priorities.
- Ability to use a computer/Microsoft Office applications.
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