Let’s grow tomorrow, together!
Would you like to join a team of passionate people who will help you learn and actively participate in the company`s success like nowhere else? then read on and become part of our story!
How will you help change the landscape of technology and innovative products at medicago?
Your role:
Under the supervision of the senior director of manufacturing science and technology, the incumbent will have the responsibility for the industrialization of the formulation and filling of vaccine candidates as well as the technical transfer to cmosLead technical investigation on drug product manufacturing and responsible for stage 3 validation of the drug product processes.
Your responsibilities:
Responsible to be drug product technical and industrial expert
This scientific leadership role will be responsible for industrialization of adjuvanted formulation, investigating physico-chemical characterization methods, scale up and tech transfer of medicago vaccine portfolio
Working in collaboration with smes from r&d, quality, operations, validation and external partner sites to support technology transfer of drug product processes to external manufacturing sites and product licensure.
Provide technical representation and subject matter expertise (sme) in cross functional formulation, process and analytical investigations for commercial production processes.
Interface extensively in a matrixed environment with process and analytical development teams for process investigation support, assess new analytical technologies, support on-going process characterization and post-approval changes
Responsible for drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, and sample plans
Support review and approval of batch records and standard operating procedures.
Serve as manufacturing /technical point of contact on specific workstreams/sub-projects, attending teleconferences with cmos and internal teams, following up with stakeholders on action items
Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior leadership
Work with cmos to compile and trend dp manufacturing process data during manufacturing campaigns.
Required qualifications:
Degree in an engineering or scientific discipline with experience in biopharmaceutical manufacturing science & technology/ manufacturing/ process engineering/ quality.
B.sWith 10+ years of industrial experience.
Solid foundation in formulation, analytical and chemistry
Prior experience in protein drug product industrial formulation and adjuvanted products preferred
Strong knowledge of biologics drug product manufacturing operations and equipment (sterile filtration, formulation, sterile filling), with prior experience in manufacturing, technical operations or manufacturing science and technology.
Experience with regulatory filings and submissions.
Effective communication skills and the ability to write detailed technical reports.
Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment.
Medicago is changing the game!
Our vision: a world better prepared to deal with any diseaseOur mission: to create and deliver effective responses to new global health challengesInnovation, collaboration, integrity, adaptability, ownership and involvement of our colleagues are the keys to the success of our researchWe have been cultivating the future together since 1999.
Medicago`s journey is a story of innovation and perseveranceEven the company`s name - the latin name for alfalfa, the first plant we worked with - is a reminder of our culture of adaptabilityWe`re proud of our humble beginnings and our current growth and global reach.
As a pioneer in transient expression and plant-based manufacturing, medicago has always sought a more effective way to improve human healthWith nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.
Medicago promotes an open and inclusive work environment for all our employees.
It is important that you are legally entitled to work in the us or canada at the time the job offer is made to youYou may be asked to provide proof of eligibility.
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