CMC Manager

Lumos Pharma; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

Lumos Pharma is seeking a Manager of Chemistry, Manufacturing, and Controls to oversee the development of novel therapies for rare diseases. This role involves collaboration with cross-functional teams, project management, and regulatory compliance, focusing on innovative solutions to improve patient outcomes. The ideal candidate will have a Ph.D. and experience in CMC product development.

Benefits

Generous health and welfare benefits

Company-paid dental and vision benefits

Short-term and long-term disability

Basic life insurance

Health Reimbursement Arrangement

8 weeks of fully paid parental leave

Qualifications

• Proven experience in CMC (DS &/or DP) product development and tech transfer.
• Excellent project management skills with a track record of successful project delivery.
• Strong communication skills, both written and verbal.

Responsibilities

• Collaborate with cross-functional teams to develop and implement CMC strategies.
• Lead CMC-related project management activities.
• Prepare and contribute to FDA and global regulatory submissions.

Skills

Analytical skills

Business acumen

Communication skills

Decision-making/Judgment skills

Innovation

Relationship building

Managerial skills

Education

Ph.D. or equivalent in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field

Job description

Transforming Lives with Breakthrough Therapies!

At Lumos Pharma, we are on a mission to revolutionize the treatment of rare diseases. As a cutting-edge clinical-stage biopharmaceutical company, we are focused on developing innovative therapies where the need is greatest and the science is clear. Our unwavering commitment is to bring safe, effective, and innovative treatments to patients through a strategy that values time and cost efficiency.

Join us in our pursuit to make a difference. Together, we can change the future of medicine!

The Manager of Chemistry, Manufacturing, and Controls (CMC) Product Development (DS &/or DP) plays a crucial part in advancing the development of novel therapies for rare diseases, overseeing the critical aspects of product development and technology transfer through commercialization.

ESSENTIAL FUNCTIONS

• Collaborate with cross-functional teams to develop and implement CMC strategies aligned with project goals and regulatory requirements.
• Provide expertise in designing and optimizing manufacturing processes for rare disease therapeutics.

Project Management:

• Lead CMC-related project management activities, ensuring timely and successful execution of development plans.
• Coordinate with internal teams and external partners to achieve project milestones and objectives.

Regulatory Compliance:

• Stay abreast of regulatory guidelines and requirements for CMC development for rare disease therapeutics.
• Prepare and contribute to FDA and global regulatory submissions.
• Oversee and manage relationships with external contract development and manufacturing organizations (CDMOs) and other vendors.
• Ensure adherence to quality standards and timelines for outsourced activities.
• Identify potential risks and challenges and develop proactive mitigation plans.
• Work with the quality and regulatory teams to address compliance or quality issues.

Budget Management:

• Develop and manage budgets related to CMC activities, ensuring efficient allocation of resources.

POSITION QUALIFICATIONS

• A qualified candidate will possess the following competencies.
• Analytical skills refer to an individual’s ability to gather raw data and process it into meaningful form.
• Business acumen looks at the ability of the individual to understand and discriminate between various business-related topics and issues.
• Communication skills measure the extent to which an individual communicates efficiently and clearly in written and verbal forms, understands others’ messages and intent, and receives and processes feedback.
• Decision-making/Judgment skills examine the individual’s ability to select a practical course of action while controlling resources and expenditures.
• Innovation is the ability to go beyond the conventional, be willing to try different solutions, and encourage new ideas from employees and co-workers.
• Relationship building involves the ability to establish and maintain a good rapport and cooperative relationships with customers and co-workers.
• Managerial skills examine the individual’s ability to achieve desired outcomes by setting goals and priorities that deliver results.

SKILLS & ABILITIES

• Advanced degree (Ph.D. or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• Proven experience in CMC (DS &/or DP) product development and tech transfer within the biotechnology or pharmaceutical industry, with a focus on rare diseases.
• If possible, understand analytical and regulatory requirements, including experience with global regulatory submissions.
• Excellent project management skills with a track record of successful project delivery.
• Ability to work effectively in a collaborative, cross-functional team environment.
• Strong communication skills, both written and verbal.

WORK ENVIRONMENT

This position can work remotely in the United States.

WHAT YOU CAN EXPECT AS A LUMOSIAN

• Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.
• Lumos covers 95 – 85% of medical premium
• Health Reimbursement Arrangement
• 8 weeks of fully paid parental leave for all new parents