Senior Process Engineer - Skin Substitute Therapeutics (REMOTE)
Position requires scale-up and process optimization relative to advanced wound care pharmaceutical devices (class II).
The device is intended for use in skin substitute therapeutics.
The product is fully developed but is not currently meeting the market demand.
Increase supply can be achieved by increasing yield and / or by scaling up of the process (~4x).
Experiences and knowledge with scale up, lean operations (OpEx), skin substitutes, regenerative products, wound care, bioengineering living cell therapeutics, 510(k) and lean manufacturing tools.
This position will part of a multidisciplinary team consisting of MS&T, Quality Assurance, Supply chain and Regulatory Affairs.
Education and Skills Requirements:
B.S. with 6+ years required; or M.S. with 4+ years of experience. Ph.D. preferred.
Must have Wound care, bioengineering living cell therapeutics, 510(k) and lean manufacturing tools.
Strong organization, problem-solving, and project management skills.
Rigorous attention to detail, ability to maintain knowledge on technical areas and update documents to reflect improvements.
Excellent communication skills: able to contextualize work to external contacts, speak responsibly, and teach others about functional area.
Highly motivated self-starter and effective team player.
Experience with Life Sciences, Medical Device, skin, wound care vital
Knowledge of cGMP requirements.
Experience working with CMO is preferred.
Candidates without the appropriate "Medical Device" experience and qualifications will not be reviewed.
This position is 100% REMOTE
Valid through: 8/30/2020
$180K — $275K + $120 hourly
32 days ago
$200K — $250K + stock options, etc.