Director, Development and Clinical Services
: Job Details :

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra?Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

The role:

The Director of Development & Clinical Services is responsible for overseeing all development and clinical activities at the site, from early-stage development through to late-phase clinical trials and regulatory approval, prior to commercial launch. This role is accountable for establishing the site's capacity and capabilities in key areas such as lyophilization, formulation, analytical method optimization, and clinical manufacturing.

The incumbent will ensure the efficient and reliable clinical manufacturing throughout the entire product lifecycle, guiding projects from development through regulatory approval and into commercial operations. They will serve as the primary representative of the site's Development and Clinical capabilities in customer interactions, ensuring strong relationships and seamless communication with clients.

Collaboration with the sales and marketing teams will be essential to align clinical and development strategies with broader business objectives. The Site Head will be accountable for managing the department's budget, P&L responsibilities, and the overall operational needs to drive long-term value creation.

As a member of the site leadership team, the Site Head is expected to uphold and exemplify the company's values and culture in all aspects of their role.

The responsibilities:

• Lead the Development and Clinical Services business for the site.
• Build the development and clinical capacity and capabilities including hiring, training, and team engagement.
• Incorporate innovation and continuous improvements to deliver excellence for Simtra and the customers
• Support and develops data acquisition and new technologies such as digital twin or enhanced DOE analysis
• Drive the site Development and Clinical P&L to achieve short-term goals and long-term value creation
• People and organization leadership including organization design, staffing, engagement, development
• Manage business risks, issues, dependencies
• Deliver effective business, organization, and customer updates on a regular basis.
• Ensure regulatory requirements and GMP standards are adhered to.
• Oversee the change control process with customers and internal teams.
• Identify opportunities for improvement and ensure team takes ownership and drive results.

Required qualifications:

• Bachelor's degree in Engineering, Biotechnology, Chemistry or Biology required. PhD preferred.
• 8-10 years of experience in product development or related experience required
• 5 years of leadership experience required
• Sound knowledge and experience in a development and/or scientific environment.
• Customer facing experience preferred.
• Previous P&L responsibility preferred.
• Strong business and financial acumen.
• Experience in continuous improvement projects.
• Innovative and strategic thinking.
• Strong communication and interpersonal skills, able to effectively interact with and influence stakeholders at all levels.
• Demonstrated ability to lead collaborative initiatives and promote a culture of continuous learning and excellence.
• Computer proficiency in Microsoft Project, Word, Excel, and Outlook and the ability to use enterprise software tools.
• Strong preference for candidates to be local to site of responsibility.

Physical Requirements

• Duties may require overtime work, including nights and weekends.
• Position requires sitting for long hours but may involve walking or standing for periods of time.
• Use of hands and fingers to manipulate office equipment

In return, you'll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy

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